System and method for detection of target substances

ABSTRACT

A system and method includes a test container for detecting a target substance in a consumable sample, where the test container includes a test container body defining a test container top, a test container bottom opposing the test container top, a first chamber proximal the test container top, and a second chamber proximal the test container bottom, a magnetic diaphragm situated between the first chamber and the second chamber, the magnetic diaphragm obstructing flow of the consumable sample, and the magnetic diaphragm including a magnetic element embedded in the magnetic diaphragm, and a driving element geometrically complementary to the first chamber, the driving element including a consumable sample grinding feature protruding from a surface of the driving element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 15/265,171 filed 14 Sep. 2016, which is a Continuation-In-PartApplication of U.S. application Ser. No. 14/498,298, filed 26 Sep. 2014,which is a Continuation-in-Part Application of U.S. application Ser. No.14/227,543, filed on 27 Mar. 2014, which claims the benefit of U.S.Provisional Application Ser. No. 61/874,590, filed on 6 Sep. 2013, andU.S. Provisional Application Ser. No. 61/806,425, filed on 29, Mar.2013, which are each incorporated herein in their entirety by thisreference. This application claims priority to U.S. Provisional No.62/218,196 filed 14 Sep. 2015 and U.S. Provisional Application No.62/234,748 filed 30 Sep. 2015, which are each incorporated in theirentireties by this reference.

TECHNICAL FIELD

This invention relates generally to the consumer assay device field, andmore specifically to an improved system and method for detection oftarget substances within a consumable.

BACKGROUND

A wide variety of consumables (e.g., foods, beverage, cosmetics, etc.)contain contaminants, toxins, allergens, and/or other substances thatare of interest to all or specific types of consumers. In particular, inrecent years, an increase in the number of consumers with an identifiedallergy (e.g., gluten allergy, dairy allergy, fish allergy, nut allergy,soy allergy, cosmetic allergy, etc.) has contributed to a number ofproducts that omit ingredients having an associated allergen; however,such consumers are still at risk for consuming items with a harmfulsubstance when the items do not have adequate labeling or documentation.Various systems and methods exist for detection of toxins and harmfulsubstances present in a sample; however, current systems and methods aredeficient due to one or more of: a time-intensive manner of receivingtest results, a labor-intensive manner of receiving test results, anon-automated manner of processing samples, system bulk, systemnon-portability, and other factors that contribute to inconveniencing aconsumer using such systems.

Due to these and other defects of current systems and methods fordetecting harmful substances in consumables, there is thus a need for animproved system and method for detecting target substances. Thisinvention provides such a system and method.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depict an embodiment of a system for detection of harmfulsubstances;

FIGS. 2A and 2B depict embodiments and variations of a portion of asystem for detection of harmful substances;

FIGS. 3A and 3B depict first variations and examples of a portion of asystem for detection of harmful substances;

FIGS. 4A and 4B depict second variations and examples of a portion of asystem for detection of harmful substances;

FIG. 5 depicts an example of a portion of a system for detection ofharmful substances;

FIGS. 6A and 6B depict variations of a valve mechanism in an embodimentof a system for detection of harmful substances;

FIGS. 7 and 8 depict variations and configurations of a portion of asystem for detection of harmful substances;

FIGS. 9A-9E depict variations and configurations of a portion of asystem for detection of harmful substances;

FIG. 10 depicts one variation of a portion of a system for detection ofharmful substances;

FIGS. 11A and 11B depict example outputs of a system for detection ofharmful substances;

FIG. 12 depicts an example output of a system for detection of harmfulsubstances;

FIG. 13 depicts a flowchart schematic of an embodiment of a method fordetection of harmful substances;

FIG. 14 depicts a schematic of an embodiment of a method for detectionof harmful substances;

FIG. 15 depicts a schematic of an embodiment of a system for detectionof harmful substances;

FIGS. 16A-16B depict schematics of an embodiment of a system fordetection of harmful substances;

FIG. 17 depicts a variation of a portion of a system for detection ofharmful substances;

FIG. 18 depicts a variation of a test container of a system fordetection of harmful substances;

FIG. 19 depicts a variation of a diaphragm of a system for detection ofharmful substances;

FIG. 20 depicts a variation of a system for detection of harmfulsubstances;

FIG. 21 depicts a variation of an analysis module for detection ofharmful substances;

FIG. 22 depicts a variation of an analysis module for detection ofharmful substances; and

FIGS. 23-25 are schematic representations of a first, second, and thirdexample of the magnetic diaphragm transitioning from the cohesiveconfiguration to the broken configuration.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of preferred embodiments of the invention isnot intended to limit the invention to these preferred embodiments, butrather to enable any person skilled in the art to make and use thisinvention.

1. Overview

As shown in FIGS. 1 and 16B, an embodiment of a system 100 for detectinga target substance in a consumable sample includes: a test container 105and an analysis device 205 configured to detect presence of the harmfulsubstance at the test container 105. In an embodiment, the testcontainer 105 includes: a first chamber 110 for receiving the consumablesample, a driving element 120 configured to generate a homogenizedsample upon processing of the consumable sample, a second chamber 130configured to receive the homogenized sample and combine it with aprocess reagent to produce a dispersion, and analysis chamber 140configured to expose the dispersion to a detection substrate 150 fordetection of the harmful substance. In an embodiment, the analysisdevice 205 includes: a receiving port 210 configured to receive the testcontainer 105, an optical sensing subsystem 220 configured to enabledetection of the presence of the harmful substance at the detectionsubstrate 150, a mixing module 230 configured to mix the homogenizedsample with a process reagent, and a processing and control system 240configured to receive and process signals from the optical sensingsubsystem 220, thereby producing an output indicative of the presence ofthe harmful substance in the consumable sample.

As shown in FIGS. 17-18, another embodiment of a system 100 includes atest container 105 for detecting a target substance in a consumablesample, where the test container 105 defines a first chamber 110, and asecond chamber 130, a magnetic diaphragm 160′ situated between the firstchamber 110 and the second chamber 130, the magnetic diaphragm 160′obstructing flow of the consumable sample, the magnetic diaphragm 160′including one or more magnetic elements 163′, 163″ embedded in themagnetic diaphragm, and a driving element 120 geometricallycomplementary to the first chamber 110, the driving element including aconsumable sample grinding feature extending from a surface of thedriving element 120.

The system 100 functions to receive and process a sample of a consumable(e.g., food, beverage, cosmetic, etc.) in order to enable detection ofone or more harmful substances within the sample. In examples, theharmful substances can include any one or more of: an allergen (e.g.,gluten allergen, a dairy-derived allergen, a nut allergen, a fishallergen, an egg-derived allergen, etc.) a toxin, a bacterium, a fungus,a pesticide, a heavy metal, a chemical or biological compound (e.g., afat, a protein, a sugar, a salt, etc.), and any other suitable harmfulsubstance. The system 100 is preferably configured to impose minimalrequirements upon a consumer using the system 100, in terms oflabor-intensiveness, time-intensiveness, and cost-intensiveness. Assuch, the system 100 is preferably configured to automatically orsemi-automatically process the sample in a manner that is intuitive tothe consumer, and to quickly provide information regarding presence ofthe harmful substance(s) within the sample. The system 100 is preferablyconfigured to be portable and compact, such that the user canconveniently carry the system 100 during his/her daily life (e.g., toestablishments); however, in some alternative variations, the system 100can be configured to be non-portable and/or non-compact. Preferably, thesystem 100 has reusable and disposable components, and in somevariations portions of the system 100 are configured to be single-use(e.g., the test container(s), portions of a test container) while otherportions of the system 100 are configured to be reusable (e.g., theanalysis device). However, in other variations, the system 100 caninclude only reusable components or only disposable components.

In an example workflow, the system 100 is configured to receive a sampleat a first chamber of a test container, to homogenize the sample, and tomix the homogenized sample with at least one process reagent to enabledetection of one or more harmful substances within the sample at ananalysis device. In the example workflow, a user of the system 100 woulddeposit the sample into the test container, perform a small amount oflabor to facilitate homogenization of the sample, and place thecontainer in the analysis device for further processing and analysis ofthe sample, such that the user has minimal interaction with the system100 in generating an output. In another example workflow, the system 100is configured to receive a sample at a first chamber of a testcontainer, to homogenize the sample, and to mix the homogenized samplewith at least one process reagent to enable detection of one or moreharmful substances within the sample at an analysis device. In thisexample workflow, the system 100 is configured to receive and process asample without any labor required by a user, in order to enabledetection of a target substance within the sample in a fully-automatedmanner.

As shown in FIG. 15, in another example workflow, the system 100 canfunction to homogenize a food sample (e.g., with a test container cap120 including grinding elements) within a grinding chamber 110 of adisposable test container 105 as a user rotates the cap to seal the testcontainer 105. The system 100 can additionally function to mix thehomogenized sample (e.g., where the system 100 is configured tomagnetically rotate a detachable diaphragm that falls into the mixingchamber 130 after detachment of the diaphragm from the test containerwalls) with the appropriate processing reagents, to flow the consumablesample to a beginning portion of a detection substrate 150 (e.g., teststrip), to perform an optical analysis with an optical sensing subsystem220 of a complementary analysis device 205, and to display results on auser interface 250 (e.g., an indicator of whether or not allergens weredetected).

As such, the system is preferably configured to facilitateimplementation of the method 300 described in Section 2 below; however,the system 100 can additionally or alternatively be configured toperform any other suitable method.

2. Benefits

In specific examples, the system 100 and/or method 300 can conferseveral benefits over conventional methodologies used for detectingtarget substances in a sample. For example, conventional methodologiesfor allergen testing (e.g., mass spectroscopy, PCR techniques, standardELISA, etc.), can be expensive, not currently suitable for consumer use,involve many processing steps, are unable to detect target proteins(e.g., that can cause an allergic response), and/or have limitedaccuracy. In specific examples, the system 100 and/or method 300 canperform one or more of the following:

First, the technology can provide an intuitive, consumer-friendlyallergen testing device for detecting allergens in consumable sampleswhile requiring minimal human interaction with the device. For example,the technology can perform detection of potentially life-threateningallergens while only asking the user to insert a consumable sample(e.g., a food sample, a drink sample, etc.) into a test container, sealthe test container, and place the test container into an analysisdevice.

In a specific example, the user action of sealing the container (e.g.,twisting a grinding cap with interior threads onto the test container)can simultaneously (1) seal the consumable sample opening, (2) grind theconsumable sample opening at a first chamber, and (3) break a diaphragmsituated between a first and second test container chamber, therebyreleasing the magnetic diaphragm elements and the homogenized sampleinto the second chamber. Providing a grinding cap for dry grinding ofthe consumable sample can enable an easier homogenization process forcertain food types. Additionally, consumable sample homogenization priorto wet mixing in the second chamber can enable more efficient anduniform reactions between the homogenized sample and processingreagents. In another specific example, the test container can define akeyed profile with asymmetric sides and/or ends of the test container,thereby ensuring that the test container can only be inserted into theanalysis device in a single direction and/or angular orientation.Further, the technology can possess a form factor and design enablingdiscreteness and/or portability. For example, the technology can behandheld, mobile and/or possess a footprint enabling the technology tobe easily transported (e.g., in a purse, in a pocket, in a backpack,etc.) for on-the-go allergen testing (e.g., at a restaurant, at aworkplace, etc.). In another example, mixing elements can be embedded inthe diaphragm, so as to minimize loose mixing elements in the secondchamber (e.g., a wet mix chamber). A lack of loose mixing elementsrattling in the test container can minimize unnecessary noise andprovide increased lifespan.

Second, the technology can additionally avoid excess components (e.g.,minimize part count) by incorporating components serving multiplepurposes in the functionality of the technology, in order to facilitatethe desired ease-of-use and small form factor. For example, the testcontainer can include a metallic diaphragm that acts both as a (1)retention element, obstructing sample flow from a grinding chamber(e.g., to grind a solid consumable sample into a homogenous sample forprocessing) to a mixing chamber (e.g., to mix a homogenous sample with aprocessing reagent for subsequent downstream analysis), and (2) as amixing element (e.g., motivated by magnetically-driven rotation based onthe diaphragm's magnetic properties) when the homogenized sample is inthe mixing chamber. The diaphragm can optionally function as aforce-generation element, wherein the diaphragm supports grindingfeatures that generate a sample grinding force (e.g., to dry-grind thesample). Additionally or alternatively, in another example, the testcontainer can include a grinding cap that acts as (1) a mechanism togrind a consumable sample into a homogenized sample for processing, (2)a sealing mechanism to prevent consumable sample backflow out of thetest container, and (3) an actuating mechanism that applies a force(e.g., cracking force) to the metallic diaphragm, thereby transitioningthe metallic diaphragm from retention mode to mixing mode. In examples,the technology can additionally or alternatively include disposable testcontainers including the requisite allergen detection materials, suchthat the technology can be used without cleaning, resetting, and/orrefilling of test containers and/or analysis devices.

Third, the technology can quickly provide allergen testing results so asto provide a seamless eating experience. In a specific application, thetechnology can provide an indication and/or an analysis of presence ofgluten in a food sample on the order of minutes (e.g., less than 3minutes), using an improved allergen extraction process, streamlined andautomatic sample processing, and an improved analysis protocol (e.g.,using a detection substrate). However, variations of the specificapplication can additionally or alternatively involve detection of anyother suitable type or number of allergens (e.g., gluten allergen, adairy-derived allergen, a nut allergen, a fish allergen, an egg-derivedallergen, a soy derived allergen, a peanut-derived allergen,shellfish-derived allergens, etc.) and/or any other substances ofinterest in a consumable sample, within any other suitable time frame,and/or using any other suitable substance indicator module.

Fourth, the technology provides an efficient, user-friendly device whiledetecting allergens with high specificity. In a specific application,the test container and analysis device can identify if a consumablesample has 20 parts per million (ppm) or more of gluten. Additionally oralternatively, the technology can identify any suitable combination orconcentration of allergens, in order to detect allergens at aspecificity matching FDA guidelines for restaurants to label consumablesas free of a given allergen. Further, the technology can detect withsuch specificity while requiring a minimal amount of consumable sample,so as to not significantly remove portions of the consumable for otherpurposes (e.g., consumption).

Fifth, the technology can be designed to achieve the above-mentionedfunctionality while retaining an unobtrusive design. For example, themorphological form of a test container can be reduced by efficientlypositioning and orienting components within the test container, whilestrategically directing sample flow through the components of the testcontainer. In a specific example of efficient positioning of components,a capillary-flow based detection substrate can be positioned laterallyadjacent to a grinding chamber situated above a mixing chamber. In aspecific example of strategic directing of sample flow, the flow caninclude gravitationally driven flow along both the longitudinal axis andlateral axis of the test container in order to leverage both downwardgravitational flow and upward capillary flow. Further, the technologycan be assembled with materials complementing the strategic design. Forexample, the analysis device(s) and/or test container(s) can incorporatedouble shot plastics to improve durability while retainingfunctionality.

The technology can, however, provide any other suitable benefit(s) inthe context of detecting target substances in consumable and/ornon-consumable samples.

3. System

As discussed above, the system can include: a test container 105 thatincludes: a first chamber 110 for receiving the consumable sample, adriving element 120 configured to generate a homogenized sample uponprocessing of the consumable sample, a second chamber 130 configured toreceive the homogenized sample and combine it with a process reagent toproduce a dispersion, and analysis chamber 140 configured to expose thedispersion to a detection substrate 150 for detection of the harmfulsubstance. As shown in FIGS. 17-18, an embodiment of a system 100includes a test container 105 for detecting a target substance in aconsumable sample, where the test container 105 defines a first chamber110, and a second chamber 130, a magnetic diaphragm 160′ situatedbetween the first chamber 110 and the second chamber 130, the magneticdiaphragm 160′ obstructing flow of the consumable sample, and themagnetic diaphragm 160′ including one or more magnetic elements 163′,163″ embedded in the magnetic diaphragm, and a driving element 120geometrically complementary to the first chamber 110, the drivingelement including a consumable sample grinding feature extending from asurface of the driving element 120.

The test container 105 can be configured to couple to an analysis device(e.g., to cooperatively form an aligned system). In a specific example,the aligned system of the test container 105 coupled to the analysisdevice 205 can be characterized by a length less than 4 inches (e.g., alength of 3.5 inches), a width less than 1.5 inches (e.g., a width of1.0 inches), and a height less than 3.5 inches (e.g., a height of 3.1inches). In this specific example, the analysis device can possesssubstantially similar dimensions. In another specific example, the testcontainer can be defined by a height less than 3 inches (e.g., a heightof 2.5 inches). However, any suitable component of the system 100 canpossess any suitable dimensions.

Components of the system 100 can be assembled and/or coupled (e.g.,coupling between the test container 105 and the driving element 120,coupling between the test container 105 and the analysis device 205,detachable coupling between the diaphragm 160 and an interior wall ofthe first chamber 110 and/or second chamber 130, etc.) using sealants,press fitting, interference fits, tongue-and-groove interfaces, threadedinterfaces, adhesives, ultrasonic welding, clips, and/or any othersuitable mechanism.

In variations where the test container 105 can couple with the analysisdevice 205 in an alignment configuration 211 of an aligned system, thesystem 100 preferably operates when the system 100 is stood up on thebase of the analysis device 205 (e.g., with the base physically againsta non-system surface such as a table; with the base arranged at anon-zero angle to a gravity vector; etc.), as opposed to if the system100 is lying on its face (e.g., a triangular face physically connectedto the base of the analysis device 205; with the base arrangedsubstantially parallel a gravity vector; etc.). Additionally oralternatively, the system 100 is operable in any orientation in thealignment configuration 211.

In relation to a weight of the system 100, components of the system 100can have any suitable weight. In a specific example, the analysis devicecan possess a weight less than 2.5 oz, and the test container canpossess a weight less than 0.85 oz, but any suitable component can haveany suitable weight characteristic. Regarding materials of the system100, components of the system 100 can be constructed with materialsincluding: glass, metal, ceramic, plastic, or any other suitablematerial or combination thereof. In a specific example, components ofthe system 100 can be constructed using double shot plastics to enabledurability.

In a variation, components of the system 100 can be waterproof and/orwater-resistant. In an example, components of the system 100 withsurfaces exposed to interaction with a consumable sample can be coatedwith a water-repellant coating. In another example, the system 100 caninclude waterproofing sealants such as gaskets, o-rings, and/or othersuitable waterproofing components. In a specific example, the testcontainer 105 can include a waterproofing sealant arranged at the firstchamber 110 along the circumference of the consumable reception opening112, such that waterproofing sealant can act as a sealing intermediarybetween the first chamber 110 and the driving element 120 in response tocoupling of the a first chamber 110 and the driving element 120 by theuser. Additionally or alternatively, components of the system 100 canmaintain functionality upon exposure of different components of thesystem to different types of consumable samples (e.g., of varyingviscosity, chemicals, liquid, solid, gas, etc.). However, the system 100can include any suitable waterproofing element and components of thesystem 100 can have any suitable resilience.

However, the system 100 can possess any suitable mechanicalcharacteristic.

3.1 System—Test Container

As noted above and shown in FIGS. 1 and 2A-2B, in an embodiment, thetest container 105 includes: a first chamber 110 for receiving theconsumable sample, a driving element 120 configured to generate ahomogenized sample upon processing of the consumable sample, a secondchamber 130 configured to receive the homogenized sample and combine itwith a process reagent to produce a dispersion, and analysis chamber 140configured to expose the dispersion to a detection substrate 150 fordetection of the harmful substance.

Regarding test chamber components, the first chamber 110, the secondchamber 130, and the analysis chamber 140 (e.g., a detection substrate150 of an analysis chamber 140) preferably defines a consumable samplefluid path through the test container 105. The consumable sample canpreferably be characterized by different phases (e.g., solid phase,liquid phase, gaseous phase) throughout the sample fluid path. Forexample, a solid consumable sample can be received at the consumablereception opening 112 of the first chamber 110. Upon grinding of thesolid consumable sample in the first chamber 110, and mixing of thehomogenized consumable sample in the second chamber 130, the consumablesample is preferably in a liquid dispersion phase for transfer to adetection substrate 150 of an analysis chamber 140. However, theconsumable sample can have any suitable phase along the sample fluidpath. Consumable sample and/or other fluid flow through the sample fluidpath can be gravitationally driven, magnetically driven, capillarydriven, pressure driven, and/or driven through any suitable mechanism.However, flow characteristics of the sample and/or the sample fluid pathcan be configured in any suitable manner.

However, the test container 105 and/or components of the test container105 can possess any suitable characteristics.

3.1.A Test Container—First Chamber

The first chamber 110 functions to receive and facilitate processing(e.g., homogenization) of a consumable sample that the user intends toanalyze for presence of a harmful substance (e.g., an allergen). In anembodiment, the first chamber 110 preferably includes a consumablereception opening 112 configured to receive the consumable sample fromthe user, and a second opening 114 configured to deliver a homogenizedsample generated from the consumable sample into the second chamber 130for further processing. In a specific example, the first chamber 110 candefine a consumable reception opening 112 and a second opening 114opposing the consumable reception opening 112. In another specificexample, a first chamber 110 can be positioned proximal the testcontainer top 106. However, the first chamber 110 can be positioned atany suitable location relative any suitable component of the system 100.

The consumable reception opening 112 can be configured to passivelyreceive the consumable sample, or can additionally or alternatively beconfigured to actively facilitate reception of the consumable sample,for instance, by transmitting a positive/negative pressure at theconsumable reception opening 112 that drives the consumable sample intothe first chamber 110, by providing a mechanism (e.g., scoopingmechanism, suction mechanism) that guides the consumable sample into theconsumable reception opening 112, and/or by providing any other suitablemechanism for active delivery of the consumable sample into the firstchamber 110. The consumable reception opening 112 is preferably at asuperior portion of the first chamber 110, in the orientation shown inFIGS. 2A and 2B, such that gravity facilitates transfer of theconsumable sample, during processing, toward a second chamber 130inferior to the first chamber 110; however, the consumable receptionopening 112 can alternatively be configured at any other suitablelocation along the length of the first chamber 110. Additionally oralternatively, transfer of samples and/or process reagents throughoutthe system 100 can be facilitated with pressurization or any othersuitable means of driving material (e.g., such that gravitational forceis not required). Furthermore, in examples, the consumable receptionopening can include features (e.g., a sloped entryway into the firstchamber 110, a wide mouth relative to other portions of the interior offirst chamber 110) that facilitate reception of the consumable sample.Additionally or alternatively, the consumable reception opening 112and/or any other portion of the first chamber 110 can include a featurethat facilitates control of an amount of a consumable sample that isprocessed using the test container 105, prior to and/or after receptionof the consumable sample within the first chamber 110. For instance, thefirst chamber can include a maximum and/or minimum fill line to guidedelivery of the consumable sample into the first chamber 110 between amaximum and/or minimum range of amounts. In another example, portions ofthe test container 105 can be configured to exclude or accommodate alarger than desired volume of a consumable sample (e.g., by distributingexcess volumes of the consumable sample into another portion of thesystem 100, or by expelling excess volumes of the consumable sample fromthe system 100). In another example, the first chamber 110 canadditionally or alternatively include a sensor (e.g., a weight sensor, alight sensor, etc.) configured to measure aspects of a consumable samplereceived through the consumable reception opening 112 of the firstchamber 110. The first chamber can additionally or alternatively includea user indicator element in communication with the sensor, the userindicator element configured to present a user indicator that indicateswhether a sufficient and/or excess amount of consumable sample has beenplaced in the first chamber 110 to the user. In a specific example, thefirst chamber can include a weight sensor configured to measure theweight of the consumable sample in the first chamber 110, where a userindicator element of the first chamber can present a user indicator(e.g., “too much,” a sad face, etc.) in response to the measured weightexceeding a threshold weight. In examples, the consumable receptionopening 112 can have a diameter or width between 10 and 20 mm; however,the consumable reception opening can alternatively have any othersuitable dimensions.

The consumable sample is preferably a food sample potentially containinga harmful substance (e.g., an allergen), and is preferably anunprocessed food sample, such that the user can gather an insubstantialvolume of a food substance that he/she intends to consume for a meal,and deliver it into the consumable reception opening 112 of the testcontainer 105 for processing and analysis. In this example, the foodsample can include a mixture of different food items (e.g., differentcomponents of an entrée), can include a single food item (e.g., a singlecomponent of an entrée), and/or can include a sequence of different fooditems (e.g., a sequence of components from an entrée). The food samplecan be cored, spooned, tweezed, and/or processed from a bulk volume offood in any other suitable manner. However, in variations, theconsumable sample can include any one or more of a: beverage sample(e.g., volume of a mixed drink), cosmetic substance (e.g., volume ofmakeup, volume of lotion, volume of fragrance, volume of soap, etc.),and any other sample potentially containing a substance that is harmfulto the user. In variations, the consumable sample can have a volume ofbetween 1 and 7 mL prior to processing within the first chamber 110;however, the consumable sample can alternatively have any other suitablevolume.

The second opening 114 functions to deliver a homogenized sample (e.g.,entirely homogenized, substantially homogenized, etc.) generated fromthe consumable sample into the second chamber 130 for furtherprocessing. The second opening 114 is preferably at an inferior portionof the first chamber 110 relative to the consumable reception opening,in the orientation shown in FIGS. 2A and 2B, such that gravityfacilitates transfer of the consumable sample, during processing, towarda second chamber 130 inferior to the first chamber 110; however, thesecond opening 114 can alternatively be configured at any other suitablelocation along the length of the first chamber 110. Furthermore, inexamples, the second opening 114 can include features (e.g., a slopedentryway into the second chamber 130, a wide mouth relative to otherportions of the interior of first chamber 110) that facilitate deliveryof the consumable sample out of the first chamber 110. In examples, thesecond opening 114 can have a diameter or width between 10 and 20 mm;however, the consumable reception opening can alternatively have anyother suitable dimensions.

The first chamber 110 preferably defines an internal enclosed cavityopen only at the consumable reception opening 112 and the second opening114, in order to facilitate processing of the consumable sample, withinthe first chamber 110, in a desired direction. However, the firstchamber 110 can additionally or alternatively include venting and/ormetering features that facilitate processing of the consumable sample ina controlled manner. The volume of the first chamber 110 is preferablysubstantially small, in order to contribute to the compactness of thetest container, and in order to accommodate a small volume of theconsumable sample, such that the user does not feel as though he/she issacrificing a sufficient portion of his/her food. In variations, thefirst chamber 110 has an internal volume of between 1 and 7 mL betweenthe consumable reception opening 112 and the second opening 14; however,the first chamber 110 can alternatively define any other suitablevolume.

In morphology, the internal cavity of the first chamber 110 preferablyhas a uniform cross section over a majority of the length of the firstchamber 110, in order to facilitate processing of the consumable samplein a uniform manner throughout the length of the first chamber 110;however, the cross section of the first chamber 110 can alternatively benon-uniform. Additionally, the internal cavity of the first chamber 110preferably includes features that facilitate processing of theconsumable sample by other elements of the test container 105 (e.g., thedriving element 120, as described in further detail below. As such, inone example, an interior portion (e.g., wall) and/or an exterior portion(e.g., exterior surface) of the first chamber 110 can include threads116, as shown in FIG. 2B, that facilitate screwing of a driving element120 within/about the first chamber 110 in processing the consumablesample toward the second opening 114. In another example, an interiorportion or exterior portion (e.g., wall, surface) of the first chamber110 can be substantially smooth and/or have low friction to facilitatesliding of a driving element 120 between the consumable receptionopening 112 and the second opening 114 of the first chamber 110. Thefirst chamber 110 can, however, include any other suitable features thatfacilitate processing of the consumable sample in cooperation withanother element (e.g., a driving element) of the system 110. Forinstance, the first chamber 110 can include a fill line configured toguide a user in providing a desired amount of the consumable sample(e.g., such that an amount of the consumable sample provided by the useris above a lower critical limit and below an upper critical limit).

In a variation, the first chamber can house a mixing reagentfacilitating homogenization of the consumable sample in the firstchamber 110 (e.g., by a grinder 122 of a driving element 120). Mixingreagents can include water, a processing reagent, saline, and/or anysuitable reagent facilitating consumable sample homogenization and/ordown-stream processing of the consumable sample (e.g., at an analysischamber 140). The mixing reagent is preferably housed in the firstchamber 110 prior to reception of the consumable sample through theconsumable reception opening 112, but can additionally or alternativelybe introduced into the first chamber 110 during reception of theconsumable sample into the first chamber 110, and/or after reception ofthe consumable sample into the first chamber 110. In a specific example,mixing reagent can be contained within a diaphragm 160 positionedbetween the first chamber 110 and the second chamber 130, where thediaphragm 160 can define mixing reagent holes (e.g., at a roof 164and/or broad face of the diaphragm 160) configured to facilitatemovement of the mixing reagent from the diaphragm 160 into the firstchamber 110. In another specific example, mixing reagent can becontained with the interior walls of the first chamber 110 defining theinternal cavity of the first chamber 110, where the interior walls caninclude one or more mechanisms facilitating introduction of mixingreagent into the first chamber 110 at any suitable time (e.g., portholes for user reagent injection, reagent-containing pods within theinterior walls that rupture upon cap tightening, etc.). However, thefirst chamber 110 can include any suitable structural elements forfacilitating interaction between the consumable sample and mixingreagent at the first chamber 110.

However, the first chamber 110 and/or components of the first chamber110 can be configured in any suitable fashion.

3.1.B Test Container—Driving Element

The driving element 120 (e.g., test container cap) functions to interactwith the first chamber and to facilitate generation of a homogenizedsample upon processing of the consumable sample toward the secondopening 114 of the first chamber 110. As such, the driving element 120preferably has a morphological form that complements or mates with amorphological form of the first chamber 110 (e.g., an interiormorphology of the first chamber, an exterior morphology of the firstchamber) in providing a mechanism that transforms the consumable sampleinto a homogenized sample. In a specific example, the driving element120 is geometrically complementary to the first chamber no. Preferably,the driving element 120 has a portion (e.g., shaft 123) that interactswith an interior portion of the first chamber 110, as shown in FIGS. 2Band 3A-3B, wherein relative motion between the first chamber 110 and thedriving element 120 is guided (e.g., constrained) by the morphologicalforms of the first chamber 110 and the driving element 120. In aspecific example, the driving element includes a shaft 123 having aradius smaller than a radius of the consumable reception opening 112.The driving element can optionally include a head that functions to sealthe consumable reception opening 112. The head can have a criticaldimension (e.g., radius) larger than the inner radius and/or outerradius of the first chamber, or have any other suitable dimension. Thedriving element head can additionally or alternatively be sized forclosure of the consumable reception opening 112. The head can bearranged along an end of the shaft, preferably along the end of theshaft opposing the hollow channel opening, but can alternatively bearranged in any other suitable location.

In variations, the driving element 120 includes a grinder 122 and aplunger 128, as described below and shown in FIGS. 2A-2B and 3A-3B,however, other variations of the driving element 120 can adapt elementsor features of the grinder 122/plunger 128 in enabling processing of theconsumable sample, and/or be configured in any other suitable manner.

The grinder 122 functions to grind the consumable sample within thefirst chamber 110 during relative motion between the driving element 120and the first chamber 110, in order to produce a homogenized sample withapproximately uniformly sized particles. The homogenized sample is thendistributed into the second chamber 130 for further processing with aprocess reagent, and analysis using a detection substrate 150. In onevariation, the grinder 122 includes a shaft 123 and a set of protrusions124 coupled to the shaft 123, and is configured to grind the consumablesample during processing of the consumable sample between the consumablereception opening 112 and the second opening 114 of the first chamber110. In a specific example, the driving element 120 can include aprotrusion 124 (e.g., a consumable sample grinding feature) protrudingfrom a surface of the driving element 120. Preferably, the shaft 123 isconfigured to translate within the interior portion of the first chamber110 (e.g., with sliding motion, with rotational motion that producestranslation), and the set of protrusions 124 is configured to grind upthe consumable sample as the shaft 123 rotates and/or translates withinthe first chamber 110. As such, translation/rotation of the grinder 122relative to the first chamber 110 moves portions of the consumablesample between protrusions of the set of protrusions 124, therebygrinding the consumable sample. The shaft 123 can also include a channel125 (e.g., a hollow channel concentrically aligned with the shaft) toaccommodate a plunger that enables driving of the homogenized samplefrom the first chamber 110 to the second chamber 130; however, the shaft123 can alternatively omit a channel 125 and be substantially solid. Theprotrusion 124 preferably extends from an interior surface of thedriving element 120 (e.g., from the channel surface), but canalternatively extend from an exterior surface (e.g., from a majorsidewall face, from a shaft end, etc.) or any other suitable surface ofthe driving element. In a specific example, the driving element 120 caninclude a consumable sample grinding feature (e.g., a protrusion 124)physically connected to an interior surface of the hollow channel 125,wherein the consumable sample grinding feature extends away from theinterior surface of the hollow channel 125. The protrusion 124 canextend parallel the shaft longitudinal axis, perpendicular the shaftlongitudinal axis, at any suitable angle to the shaft longitudinal axis,spiral along the interior of the hollow channel (e.g., about the shaftlongitudinal axis), or be arranged in any other suitable configuration.The protrusion 124 can be shorter than the shaft length, longer than theshaft length, or have any other suitable length or dimension.

In this variation, the set of protrusions 124 preferably includesprotrusions having sharp points and/or a rough surface, in order tofacilitate grinding of the consumable sample. In another variation, thegrinder 122 can include a set of protrusions with pointed edges forgrinding one or more consumable samples in a solid phase (e.g., asopposed to a liquid or gaseous phase). Furthermore, the set ofprotrusions 124 can be arranged in a pattern (e.g., a radial pattern, arectangular pattern) with respect to a surface of the shaft 123.Furthermore, the set of protrusions 124 preferably has a smallinter-protrusion spacing (e.g., between 0.1 mm to 0.5 mm). However, theset of protrusions 124 can alternatively be arranged in a random mannerand/or in any other suitable manner.

In one example of this variation, as shown in FIGS. 3A-3B, the grinder122′ includes an set of protrusions 124′ arranged in a uniform radialdistribution at an inferior surface of a shaft 123′ having a concentricchannel 125′, wherein each protrusion defines a wedge-shaped footprinthaving a sharp point pointing toward the channel 125′ of the shaft. Inthis example, the set of protrusions 124′ includes 6 wedge-shapedprotrusions; however, variations of this example can include any othersuitable number of protrusions (e.g., between 4 and 12 protrusions)defining any other suitable morphology. Furthermore, in this example,the shaft includes exterior threads 121 configured to enable translationof the shaft 123 within the first chamber 110′, as the shaft rotates incooperation with mating threads 116 within the interior of the firstchamber 110′. As shown in FIG. 17, in a specific example, the drivingelement 120 can include a threaded shaft 123 including threads 121 alongthe exterior surface of the threaded shaft 123, and wherein a drivingelement feature (e.g., a protrusion 124, a plunger 128, etc.) protrudesparallel a longitudinal axis of the driving element. However, variationsof this example of the grinder 122′ can include protrusions having anon-uniform and/or a non-radial arrangement. Furthermore, the shaft andthe first chamber 110 can be alternatively configured such that matingthreads 116 at an exterior surface of the first chamber are configuredto mate with a portion of the grinder 122′ in order to facilitaterelative motion between the grinder 122′ and the first chamber 110during grinding.

In another variation, as shown in FIGS. 4A and 4B, the grinder 122includes a set of protrusions 124 at an interior surface 126 of thegrinder 122, wherein the interior surface 126 is configured to beparallel to a corresponding surface within the first chamber 110. Assuch, in this variation, translation and/or rotation of the grinder 122about/within the first chamber 110 moves portions of the consumablesample between protrusions of the set of protrusions 124, therebygrinding the consumable sample. The grinder 122 in this variationincludes a plunger opening 127 configured to accommodate a plunger thatenables driving of the homogenized sample from the first chamber 110 tothe second chamber 130; however, the grinder 122 can alternatively omita plunger opening 127 and be substantially solid. In this variation, theset of protrusions 124 preferably includes protrusions having sharppoints and/or a rough surface, in order to facilitate grinding of theconsumable sample. Furthermore, the set of protrusions 124 can bearranged in a pattern (e.g., a radial pattern, a rectangular pattern)with respect to the interior surface 126 of the grinder 122 (e.g., aboutan opening 127 in the grinder 122), or arranged in any other suitablemanner.

In one example of this variation, as shown in FIGS. 4A and 4B, thegrinder 122″ includes an set of protrusions 124″ arranged in a uniformradial distribution at an interior surface having a concentric plungeropening 127″, wherein each protrusion defines a wedge-shaped footprinthaving a sharp point pointing toward the plunger opening 127″ of theinterior surface 126″. In this example, the set of protrusions 124″includes 5 wedge-shaped protrusions; however, variations of this examplecan include any other suitable number of protrusions (e.g., between 4and 12 protrusions) defining any other suitable morphology. Furthermore,in this example, the grinder 122″ includes interior threads configuredto enable translation of the grinder 122″ about an exterior portion ofthe first chamber 110″, as the shaft rotates in cooperation with matingthreads at the exterior portion of the first chamber 110″.

In another example of this variation, as shown in FIG. 17, the shaft 123can include one or more shearing protrusions 124″ configured to apply ashearing force on the consumable sample and/or the diaphragm 160. In aspecific example, the shaft 123 can include an end defining a channelopening of a hollow channel 125 of the shaft 123 (e.g., wherein thehollow channel and/or shaft terminate in the channel opening), whereinthe end of the shaft 123 includes a set of shearing protrusions 124extending along a longitudinal axis of the shaft 123, and wherein alength of the shaft 123 with the shearing protrusions 124″ can begreater than a length of the first chamber 110 (e.g., a length extendingfrom the consumable reception opening 112 to the magnetic diaphragm 160′along the longitudinal axis of the test container 105). The shearingprotrusions are preferably configured to align with the frangible regionof the diaphragm, but can be otherwise arranged. In one example, theradius of the arcuate region defined by the shearing protrusions ispreferably substantially equal to the radius of the frangible region161, but can alternatively be larger or smaller. Additionally oralternatively, a set of shearing protrusions 124″ can have any suitableorientation in relation to components of the test container 105 (e.g.,extend radially outward from the shaft end, extend radially inward fromthe shaft end, etc.). In this example, the driving element 120 canadditionally or alternatively include a set of grinding protrusions 124′(e.g., extending from an interior surface of the shaft 123, extendingfrom an interior surface of the channel 125, etc.). However, a grinder122 including a set of shearing protrusions can be otherwise configured.

Other variations of the grinder 122 can additionally or alternativelyoperate using any other suitable mechanism. For instance, the grinder122 can operate by one or more of: forcing the consumable sample througha screen (e.g., a mesh screen), crushing the consumable sample (e.g., asin a pill crusher), processing the consumable sample (e.g., with ablade), grinding the consumable sample (e.g., with a mortar-and-pestle,with a grinding barrel, etc.), or in any other suitable manner.

The plunger 128 (e.g., plunging element 128) functions to facilitatedriving of homogenized portions of the consumable sample into the secondchamber 130 after and/or during processing by the grinder 122. Theplunger 128 can optionally function as a cracking force generator, andfunction to break the diaphragm into one or more constituent pieces. Invariations of the test container 105 including a diaphragm 160, theplunger 128 can additionally or alternatively function to transition thediaphragm 160 between a first configuration and a second configuration,as described in further detail below. In a variation shown in FIG. 3A,the plunger 128 can include a plunger shaft 129 and a stop 29, whereinthe plunger shaft 129 is configured to pass through a channel 125 orplunger opening 127 of the grinder 122, in order to facilitate drivingof the homogenized sample into the second chamber 130. The stop 29 isthen configured to constrain a range of motion of the plunger 128, suchthat the plunger cannot pass entirely into the first chamber in anuncontrolled manner. Preferably the plunger shaft 129 is a cylindricalshaft; however, the plunger shaft 129 can alternatively have any othersuitable cross-section or profile configured to facilitate driving ofthe homogenized sample into the second chamber 130, in cooperation withthe grinder 122. In particular, an inferior portion of the plunger shaft129 can be blunt (e.g., hemispherical, planar), sharp (e.g., conical,pyramidal), or have any other suitable morphology for driving of thehomogenized sample into the second chamber 130. The stop 29 preferablyhas a larger governing dimension than the plunger shaft 129 to providethe constrained range of motion; however, in other variations, the stop29 can include protrusions (e.g., tabs) extending from a surface of theplunger shaft 129, thereby obstructing motion of the plunger shaft 129into the channel 125/plunger opening 127 past the stop 29. The plunger128 can be coupled to the grinder, can be distinct from the grinder 122,or can be configured to interface with the grinder 122 in any othersuitable manner. In one example, the plunger 128 includes a cylindricalplunger shaft 129 configured to slide within a channel 125/plungeropening 127 of the grinder 122, and the stop 29 includes a plate coupledto a superior portion of the plunger shaft 129, having a diameter widerthan that of the plunger shaft 129 to constrain a range of motion of theplunger shaft 129. In a specific example, the plunging element 128 canextend along a longitudinal axis of the shaft, wherein a length of theplunging element 128 can be greater than a length of the first chamber110 (e.g., a length from the consumable reception opening 112 to themagnetic diaphragm 160′ along the longitudinal axis of the testcontainer 105), where a tip of the plunging element 128 physicallyapplies a force to the diaphragm 160 as a user couples the drivingelement 120 to the first chamber 110 (e.g., screws the driving element120 onto the first chamber 110, seals the consumable reception opening112 of the first chamber 110 with the driving element 120, etc.). In onevariation, the tip of the plunging element can be substantially alignedwith a frangible region of the diaphragm. However, the plunging element128 can be configured in any suitable fashion.

In a variation of the plunger 128, the plunger 128 can be a sprungplunger (e.g., spring-loaded plunger) operable between a compressedconfiguration and/or extended configuration and a resting configuration(e.g., equilibrium length), wherein transition from the compressedconfiguration to the resting configuration can result in an appliedmechanical force to the diaphragm 160 (e.g., a roof 164 of the diaphragm160) and/or consumable sample. The applied mechanical force can breakthe diaphragm 160 (e.g., at a frangible region of the diaphragm 160),deform the diaphragm 160, transition the diaphragm 160 from a firstconfiguration (e.g., a retention mode obstructing flow of the consumablesample through the second opening 114) to a second configuration (e.g.,a mixing mode for facilitating mixing of the consumable sample with aprocessing reagent within the second chamber 130), and/or satisfy anysuitable purpose. In a specific example, the plunging element 128 candefine a sharp tip, and the plunging element 128 can be in aspring-loaded configuration substantially within the hollow channel 125and oriented towards a channel opening defined by the shaft. In thisvariation, when the driving element 120 is mated with the first chamber110, the length of the plunger in the compressed configuration can fallshort of physically touching the diaphragm 160, and the length of theplunger in the resting configuration can extend beyond a broad face(e.g., facing the consumable reception opening 112) of the diaphragm160. Additionally or alternatively, other components of the drivingelement 120 can be spring-loaded to facilitate homogenization of theconsumable sample in the first chamber 110, application of a force tothe diaphragm 160, and/or for any suitable purpose.

In other variations, elements of the grinder 122 can additionally oralternatively be distributed within the first chamber 110, such that thefirst chamber 110 includes elements that actively enable grinding of theconsumable sample. For instance, an inferior surface of the firstchamber 110 can include at least a subset of the set of protrusions 124,such that movement of the grinder 122 processes the consumable sample incooperation with protrusions within the first chamber. In somevariations, a plunger 128 can be replaced by a driving module (e.g.,configured to provide positive and/or negative pressure within the testcontainer, configured to centrifuge the test container, etc.) thatfacilitates delivery of the homogenized sample throughout the testcontainer in a controlled manner. In still other variations, however,the driving element 120 can omit the grinder 122, the plunger 128,and/or any other features configured to process a solid and/ornon-homogenous consumable sample (e.g., beverage, cosmetic, etc.), whichwould not require grinding within a first chamber 110 prior to receptionat a second chamber. As such, in some variations of the system 100, thefirst chamber 110, the driving element 120, and/or the second chamber130 can be configured in manners that are appropriate to processing ofconsumable samples, based upon the form(s) of the consumable samples.

In a variation of the driving element 120, the driving element 120 caninclude a vacuum cavity. The vacuum cavity can be arranged at the headof the driving element 120 (e.g., at a driving element head regiondistal a shaft 123, at the driving element head region offset from theshaft, etc.), arranged along a side of the test container, or bearranged in any other suitable location. The vacuum cavity is preferablyconfigured to align with an analysis chamber 140 of the test container105 when the driving element 120 is mated with the first chamber 110,but can alternatively be misaligned. The vacuum cavity can include acavity bottom proximal a shaft 123 of the driving element 120, whereinthe cavity bottom is proximal an analysis chamber 140 of the testcontainer 105 in the mating configuration of the driving element 120 andtest container 105. The cavity bottom can define one or more fluidvacuum holes configured to align with one or more holes of the analysischamber 140 in the mating configuration. The one or more fluid vacuumholes can facilitate pressure stabilization in the analysis chamber 140and/or can drive a consumable sample (e.g., in a dispersion form)through the analysis chamber 140 (e.g., aiding the capillary flow ratethrough a detection substrate 150 of the analysis chamber 140). However,the driving element 120 can include any suitable cavities configured tofacilitate any suitable phenomenon.

However, the driving element 120 and/or components of the drivingelement 120 can include be configured in any suitable fashion.

3.1.C Test Container—Second Chamber

As shown in FIGS. 15 and 18, the second chamber 130 functions to receivethe homogenized sample after processing within the first chamber 110, tofacilitate combination of the homogenized sample with a process reagentto produce a dispersion, and to facilitate delivery of the dispersionfrom the second chamber 130 for further analysis to detect a harmfulsubstance. Preferably, the second chamber 130 includes a samplereception opening 132 and an outlet port 136 configured to facilitatedelivery of the dispersion to a detection substrate, as shown in FIG.2A. In some variations, the second chamber 130 can further include amixing element 134 configured to cooperate with a mixing module (e.g.,of an analysis device 205 in communication with the test container), tofacilitate mixing of the homogenized sample with the process reagent inthe second chamber 130. However, the second chamber 130 can additionallyor alternatively include any other suitable elements and/or beconfigured in any other suitable manner for generation of a dispersionfrom the homogenized sample.

As shown in FIGS. 15 and 18, in relation to the test container body, thesecond chamber is preferably proximal the test container bottom 107.Alternatively, the second chamber 130 can be adjacent to positioned at,proximal to, adjacent to, near, distanced from, and/or possess anysuitable positional relationship to the test container body and/or othercomponents of the test container 105 and/or analysis device 205. Inrelation to the first chamber 110, the second chamber 130 is preferablyconfigured to couple to the first chamber 110, and in variations, caninclude a unitary construction with the first chamber, can be physicallycoextensive with the first chamber 110, and/or can be coupled to thefirst chamber 110 in any other suitable manner. Furthermore, the secondchamber 130 is preferably inferior to the first chamber 110, such thatgravity facilitates transfer of the homogenized sample from the firstchamber 110 toward the second chamber 130 in the orientation shown inFIG. 2A.

As shown in FIGS. 15 and 18, in one variation, the second chamber 130 isaligned with the first chamber 110 along a longitudinal axis of the testcontainer body. In an embodiment of this variation, the first and secondchambers are aligned with the consumable reception opening 112, secondopening, sample reception opening 132, and test container bottom and/orsecond chamber bottom each normal the test container body longitudinalaxis. However, the openings can be otherwise arranged. In a secondvariation, the first and second chambers are aligned along the testcontainer body lateral axis. In this variation, the consumable receptionopening 112 can be parallel, normal, or at any other suitable angle tothe test container body longitudinal axis. However, the openings can beotherwise arranged. In a third variation, the first and second chamberscan be fluidly connected by an intervening fluid manifold, wherein thefluid manifold can connect the second opening to the sample receptionopening. The fluid manifold can have the same or different cross sectionas that of the second opening and/or the sample reception opening, orhave any other suitable cross section. The fluid manifold can bestraight, curved, bent, boustrophedonic, or have any other suitableconfiguration.

Alternatively, the first and second chambers can be aligned along anysuitable axis (e.g., lateral axis), plane, and/or angle related to thetest container 105 and/or components of the test container 105. However,the second chamber can alternatively be configured adjacent to or in anyother suitable location relative to the first chamber 110 in alternativevariations of the system 100.

The sample reception opening 132 can be configured to passively receivethe homogenized sample, or can additionally or alternatively beconfigured to actively facilitate reception of the homogenized sample,for instance, by transmitting a positive/negative pressure at the samplereception opening 132 that drives the homogenized sample into the secondchamber 130, by providing a mechanism (e.g., scooping mechanism) thatguides the homogenized sample into the sample reception opening 132,and/or by providing any other suitable mechanism for active delivery ofthe homogenized sample into the second chamber 130. The second chamber130 can define a sample reception opening 132 coextensive with (e.g.,coinciding) the second opening 114 of the first chamber 110.Additionally or alternatively, the sample reception opening 132 and/orother openings defined by the second chamber 130 can be co-extensive,fluidly connected, and/or fluidly contiguous with any suitable openingof components of the test container 105 and/or analysis device 205.Additionally or alternatively, portions of the test container 105 and/orsystem 100 can be configured to facilitate delivery of contents from thefirst chamber 110 into the second chamber 130. For instance, a portionof the driving element 120 (e.g., the plunger 128) can include a module(e.g., syringe pump, fluid delivery element) that applies positivepressure and/or delivers a wash solution from the first chamber 110 tothe second chamber 130, in order wash portions of the homogenized sampleinto the second chamber 130. The sample reception opening 132 ispreferably at a superior portion of the second chamber 130, in theorientation shown in FIG. 2A, such that gravity facilitates transfer ofthe homogenized sample, during processing, into the second chamber 130in cooperation with the driving element 120; however, the samplereception opening 132 can alternatively be configured at any othersuitable location along the length of the second chamber 130.Furthermore, in examples, the sample reception opening can includefeatures (e.g., a sloped entryway into the second chamber 130, a widemouth relative to other portions of the interior of second chamber 130)that facilitate reception of the homogenized sample. In examples, theconsumable reception opening 112 can have a diameter or width between 10and 20 mm; however, the sample reception opening can alternatively haveany other suitable dimensions.

In variations, the sample reception opening 132 is preferably configuredto facilitate transitioning of a diaphragm 160, configured to facilitatedelivery of the homogenized sample into the second chamber 130, betweena first configuration and a second configuration, as described infurther detail below; however, the sample reception opening 132 canalternatively be configured to facilitate delivery of the homogenizedsample into the second chamber 130 from the first chamber 110 without adiaphragm 160, for instance, by way of a valve (e.g., one-way valve,two-way valve) configured between the first chamber 110 and the secondchamber 130. Alternatively, the sample reception opening 132 can beconfigured to directly transfer the homogenized sample from the firstchamber 110 to the second chamber 130 without any intermediateelement(s).

In some variations, the second chamber 130 can include a mixing element134 that functions to facilitate mixing of the homogenized sample with aprocess reagent within the second chamber 130. The mixing element 134can be disposed within the second chamber 130, and/or can be coupled tothe second chamber 130 in any other suitable manner. The mixing element134 is preferably configured to cooperate with a mixing module 230 of ananalysis device 205, as described in further detail below, such that themixing element 134 and the mixing module 230 complement each other toprovide a mixing mechanism within the second chamber 130; however,variations of the system 100 can entirely omit the mixing element 134and/or the mixing module 230 and facilitate combination of thehomogenized sample with the process reagent in any other suitable manner(e.g., the process reagent can be combined with the consumable sampleduring processing within the first chamber 110). In variations, themixing element 134 can provide any one of: a magnetically-drivenmechanism of mixing, an ultrasonic mechanism of mixing, avibration-based mechanism of mixing (e.g., mechanically driven,acoustically driven), a rocking motion, a spinning-based mechanism ofmixing (e.g., by forming a vortex), a shaking-based mechanism of mixing,and any other suitable mechanism of mixing. In an example, as shown inFIG. 5, the mixing element 134 includes a magnet 135 (e.g., magneticstir bar) configured within the second chamber 130 that is configured tomagnetically couple to a complementary magnet of a mixing module 230. Inthe example, the complementary magnet can be coupled to a spinningmotor, thereby producing rotation at the magnet 135 within the secondchamber 130. In variations of the example, the magnet 135 can include apermanent magnet and/or an electromagnet. Furthermore, the magnet 135can be a distinct element within the second chamber 130, or canadditionally or alternatively be coupled to or integrated with adiaphragm 160 configured to access the second chamber 130, as describedbelow. Furthermore, variations of the example can include any suitablenumber of magnets 135 of the second chamber 130.

In variations, the second chamber 130 can be prepackaged with theprocess reagent (e.g., where the second chamber 130 houses a processingreagent), such that the homogenized sample is automatically brought intocontact with the process reagent upon transmission between the firstchamber 110 and the second chamber 130. Additionally or alternatively,the second chamber 130 and/or any other suitable portion of the testcontainer 105 can include or be coupled to a fluid delivery module(e.g., of the analysis device 205, of the test container 105, etc.) forreception of the process reagent and combination of the process reagentwith the homogenized sample or the consumable sample. For instance, theprocess reagent can be delivered from a module integrated with one ormore portions of the driving element 120 (e.g., from the plunger 128,from beneath the grinder 122), such that the process reagent does notoriginate from within the second chamber 130. As such, mixing of theconsumable sample with a process reagent can occur prior to grinding ofthe consumable sample by a driving element 120.

The process reagent preferably includes an extraction solutionconfigured to extract at least one analyte, associated with a harmfulsubstance, from the homogenized sample, that can be detected at adetection substrate and used to indicate presence of the harmfulsubstance. In an example for gluten detection, the extraction solutioncan contain 2-mercaptoethanol, or tris(2-carboxyethyl)phosphine, whichoperates by reducing disulfide prolamin crosslinking in a sample, andsolubilizes proteins in the sample to facilitate detection. Theextraction solution can additionally or alternatively contain guanidinehydrochloride, or N-lauroylsarcosine, or other disaggregating agents. Invariations for other allergens, the extraction solution can includeethanol for a dairy-derived allergen (e.g., lactose), a parvalbuminextraction solution for a fish-derived allergen, an ara-h2 extractionsolution for a nut derived allergen, an egg protein extraction solutionfor an egg-derived allergen (e.g., ovomucoid protein, ovalbumin protein,ovotransferrin protein, lysozyme protein), a tropomyosin extractionsolution for a shellfish-derived allergen, and/or any other suitableextraction solution for any other harmful substance. Furthermore,variations of the process reagent(s) can additionally or alternativelyinclude any one or more of: a reagent for lysing of a sample, a reagentfor solubilization of a sample, a reagent for buffering of a sample, areagent for dilution of a sample, and any other suitable reagent(s). Forinstance, in some variations, extraction and dilution of a sample togenerate a dispersion can involve a first process reagent for extraction(e.g., an alcohol-based solution for extraction of gluten), and a secondprocess reagent for dilution of a sample processed with the firstprocess reagent, such that the dispersion has appropriatecharacteristics for assessment at a detection substrate 150.

In variations, the second chamber 130 can be prepackaged (e.g., prior toreceipt of a consumable sample through the consumable reception opening112) with one or more mixing elements 134 (e.g., magnets, etc.), inorder to facilitate mixing of processing reagent and the consumablesample upon receipt of the consumable sample in the second chamber 130.The one or more mixing elements 134 can be prepackaged with or separatedfrom processing reagent and/or other suitable components. However, thesecond chamber can house any suitable components prior to, during,and/or after receipt of the consumable sample at any suitable componentof the test container 105.

The outlet port 136 functions to facilitate delivery of a controlledvolume (and/or rate of flow) of the dispersion, from the second chamber130, to an analysis chamber 140 for detection of the harmfulsubstance(s) within the consumable sample. The outlet port 136 ispreferably situated at an inferior portion of the second chamber, anexample of which is shown in FIG. 2B, in order to facilitate delivery ofthe dispersion from the second chamber at least in part by gravity.However, the outlet port 136 can alternatively be configured at anysuitable location relative to the second chamber. The outlet port 136preferably allows a volume of the dispersion to be transmitted to adetection substrate 150 at an analysis chamber 140 in communication withthe port, wherein the volume of the dispersion is configured so as toprovide an adequate amount of the dispersion without flooding thedetection substrate. In a specific example, an outlet port 136 of thesecond chamber 130 can be sized to be impermeable to residual particlesresulting from the breaking of a frangible region 161 of the diaphragm160 when the diaphragm is detachably coupled to the interior wall of thetest container body. However, the outlet port can have any suitabledimensions.

While the outlet port 136 can be configured to passively facilitatedelivery of the dispersion to a detection substrate at the analysischamber 140, variations of the system 100, as shown in FIGS. 6A and 22,can include an actuation system 137 configured to provide or meter acontrolled volume of the dispersion to the analysis chamber 140. In onevariation, an actuation system 137 coupled to the outlet port 136 caninclude a valve 138 that can be controllably opened and/or closed inorder to dispense the dispersion into the analysis chamber 140 with acontrolled volume and/or at a controlled time point. In an example, thevalve 138 can include a rod 31 (e.g., needle) that is biased to beclosed in a first valve configuration 32 and configured to open in asecond valve configuration 33, wherein transitioning between the firstvalve configuration 32 and the second valve configuration 33 can becontrolled by actuators (e.g., solenoids, etc.) of the test container105 and/or analysis device 205, pressurization of the test container 105(e.g., using a pneumatic mechanism), and/or in any other suitablemanner. In the example, the rod can be biased closed using a compressionspring (or other elastomeric element), and configured to transitionbetween the first valve configuration 32 and the second valveconfiguration 33 upon user input (e.g., by pushing a button on the testcontainer or the analysis device, by inputting a command at a userinterface, etc.) and/or automatically (e.g., controlled by a controllerof the system 100).

In another example, the outlet port 136 can include a material valve 138configured to transition from a first state 34 to a second state 35(e.g., reversibly, irreversibly), thereby allowing a volume of thedispersion to pass through the outlet port 136 in a controlled manner.In variations of this example, the material of the valve 138 can includeany one or more of: a material (e.g., salt, sugar, polyvinyl alcohol,etc.) configured to transition from a solid state to a dissolved state(e.g., dissolvable salt wall, dissolvable in a manner that does notaffect detection of an analyte at the detection substrate), a waxconfigured to transition from a solid state to a melted state, amaterial (e.g., foil, metals, plastics, etc.) configured to transitionfrom an unpunctured state to a punctured state, and/or any othermaterial configured to transition between states without affecting testresults (e.g., without interfering with the delivery of a volume of adispersion to a detection substrate, etc.). The transition between afirst material valve configuration (e.g., closed) to a second materialvalve configuration (e.g., open, facilitating delivery of a volume ofthe dispersion) is preferably controlled by a component (e.g., amechanical actuator, a heating element, a fluid dispersion moduledispersing fluid for dissolving the material valve, etc.) of theanalysis device 205. In a specific example, the analysis device 205 caninclude a valve motor coupled to a valve plunger that manipulates a raketo pierce a seal of the outlet port 136 in order to open the valve holeand transition the outlet port from a first to a second configuration.However, valve-controlling components of the analysis device 205 canapply any suitable force, movement, and/or action in opening and/orclosing pathways through the outlet port 136. However, the transitionfrom the first to the second valve configuration can also be controlledby components of the test container 105, actions by the user, and/or anythrough any other suitable mechanism.

In another example, the outlet port 136 can be characterized by varyinglevels of permeability to the consumable sample, homogenized sample,liquid dispersion, components of the test container 105 (e.g., diaphragm160, residual pieces from a broken frangible region of the diaphragm160, etc.), and/or other suitable materials of the test container top106 and/or sample, depending on the configuration state (e.g., betweenan open and a closed configuration) of the outlet port 136. In aspecific example where the second chamber 130 includes an outlet port136 including a valve 138, the analysis device 205 can include a valvemotor that controls the valve 138 of the outlet port 136 to operatebetween: a closed position where the outlet port 136 is impermeable toflow of the consumable sample through the outlet port 136, and an openposition wherein the outlet port 136 is permeable to the flow of theconsumable sample through the outlet port 136, and impermeable tomovement of the magnetic diaphragm 160′ through the outlet port 136. Inspecific examples, the outlet port can include flow passage features toenable and or prevent flow of sample and/or other components. The outletport can define protrusions, standoffs, biofilms, fluid blocking agents,damming agents, features affecting fluid dynamics, standoffs, and/or anyother suitable features affecting sample flow through the outlet port136. In an illustration, the outlet port 136 can include a flowregulator (e.g., a foam dam) to regulate the flow of the dispersionand/or other suitable component to the detection substrate 150. The flowregulator is preferably arranged at an interface between the outlet port136 and the detection substrate 150, but can be otherwise positioned inrelation to the outlet port 136. The flow regulator can preferablyretain a specific volume of the dispersion and/or facilitate thedelivery of a specific volume of the dispersion to the analysis chamber140. However, the outlet port 136 can possess and/or be defined by anysuitable flow passage characteristics.

In another example, the outlet port 136 can define (e.g., along with afirst chamber 110, a second chamber 130, an analysis chamber 140, etc.)a sample fluid path through which a consumable sample would travelduring operation of the test container 105 with the analysis device 205in the alignment configuration 211. The outlet port 136 can beappropriately dimensioned to define a specific fluid path. As shown inFIG. 20, for example, the outlet port 136, can be defined by testcontainer body interior walls that are straight, angled, curved, and/orwith any suitable orientation to define a corresponding sample fluidpath. In a specific example, the outlet port 136 of the second chamber110 can define a sample fluid path extending along a lateral axis of thetest container body, but can otherwise define sample fluid paths alongany suitable reference feature (e.g., any suitable axis, plane, angle,etc.) of the test container body. In specific examples, the outlet port136 can define microfluidic pathways configured to transfer theconsumable sample from the second chamber 130 to one or more suitablecomponents (e.g., an analysis chamber 140, a chamber for furtherprocessing, etc.). However, the outlet port can be otherwise configuredfor defining a sample fluid path.

In another example, the outlet port 136 can be appropriately dimensioned(e.g., based upon the viscosity of the dispersion) to allow thecontrolled volume of the dispersion to pass into the analysis chamber140. In variations of this example, positive pressure and/or negativepressure can also be used to drive the dispersion out of the port andinto the analysis chamber.

In still another example, the outlet port 136 can include a valve 138(e.g., a membrane, a film) that can be punctured or otherwisecompromised to allow a volume of the dispersion to pass through theoutlet port 136 and into the analysis chamber 140. In this example, thevalve 138 could be compromised using a needle coupled to a portion ofthe second chamber, wherein the needle could be deflected (e.g., by aportion of the analysis device 205, in combination with spring-loadingof the needle) in a manner that prevents accidental deflection by a useror other entity in contact with the test container 105. As such, theactuation system 137 can operate as a release mechanism that allows thedispersion to be conducted to a detection substrate at the analysischamber 140. The outlet port 136 and/or actuation system 137 can,however, be configured in any other suitable manner and/or include anyother suitable elements that enhance detection at a detection substrate.For instance, one variation of the outlet port 136 can include a filterproximal the port that prevents material (e.g., material that couldadversely affect detection) from passing into the analysis chamber 140and/or from reaching the detection substrate 150.

However, the second chamber 130 and/or components of the second chamber130 can be configured in any suitable manner.

3.1.D Test Container—Diaphragm

In some embodiments, as shown in FIGS. 2A, 2B, and 7, the system 100 caninclude a diaphragm 160 situated between the first chamber 110 and thesecond chamber 130, which functions to facilitate delivery of thehomogenized sample, after processing of the consumable sample, into thesecond chamber 130 in a controlled manner. In one variation, thediaphragm 160 can obstruct flow of the consumable sample from the firstchamber 110 to the second chamber 130 through the second opening 114(e.g., defined by the first chamber 110) and a sample reception opening132 (e.g., defined by the second chamber 130). In this variation, thediaphragm 160 can extend across the second opening, the sample receptionopening, the fluid manifold cross section, or across any other suitablefluid path. In a second variation, the diaphragm 160 can extend across across section of the test container chamber and segment the testcontainer chamber into the first chamber and the second chamber.However, the diaphragm 160 can be arranged at any suitable locationrelative the first chamber 110 (e.g., located substantially and/orcompletely within the first chamber 110), the second chamber 130 (e.g.,located substantially and/or completely within the second chamber 130),and/or any suitable component of the test container 105.

In one variation, the diaphragm 160 can include a set of openings 162configured to allow passage of homogenized portions of the consumablesample, during processing, into a cavity formed by the diaphragm. Inthis variation, the diaphragm can further include a roof 164 at asuperior portion of the diaphragm 160, wherein the roof 164 preventspassage of unprocessed portions of the consumable sample into the secondchamber 130. In examples of this variation, the diaphragm has a heightbetween 3 and 15 mm (e.g., 8 mm), in order to facilitate processing andtransmission of a desired volume of the homogenized sample.

In variations, the set of openings 162 of the diaphragm 160 ispreferably distributed uniformly about the second opening 114 of thefirst chamber 110 and/or the sample reception opening 132 of the secondchamber 130, in order to facilitate reception of homogenized portions ofthe consumable sample into the diaphragm 160. However, the set ofopenings 162 can alternatively be arranged in any other suitable manner.The set of openings can be located at lateral surfaces (e.g., verticalsurfaces) of the diaphragm 160, in the orientation of the diaphragm 160shown in FIG. 7, and can additionally or alternatively be located at anyother suitable surface of the diaphragm 160. Openings of the set ofopenings 162 are preferably rectangular in shape; however, the set ofopenings 162 can alternatively include openings that are any one or moreof: polygonal, ellipsoidal, circular, and any other suitable shape. Invariations, the set of openings 162 include rectangular openings thatare from 2 mm to 15 mm in height (e.g., 7 mm in height) and 0.5 to 5 mmin width (e.g., 3 mm in width); however, other variations of the set ofopenings 164 can alternatively have any other suitable dimensions.Furthermore, the set of openings 162 can include non-identical openings(e.g., in shape, in dimensions, etc.) in other variations of thediaphragm 160.

The roof 164 of the diaphragm 160 is preferably non-planar (e.g.,non-horizontally planar, in the orientation shown in FIGS. 2A and 7),and defines a concave surface facing the sample reception opening 132 ofthe second chamber 130, which promotes sliding of homogenized portionsof the consumable sample off of the roof 164 and toward openings of theset of openings 162 of the diaphragm. The concave surface can be bluntor sharp, and in examples, can include a semi-spherical surface, asemi-conical surface, a semi-pyramidal surface, a prismatic surface,and/or any other suitable surface. Alternatively, the roof 164 of thediaphragm 160 can include a planar surface, or a non-concave surface.

The diaphragm 160 can house one or more magnetic elements (e.g., one ormore magnets, reagent (e.g., mixing reagent, processing reagent),actuating elements, force-applying elements (e.g., a mixing motor,etc.), and/or any suitable components. In a specific example, as shownin FIG. 18, the diaphragm 160 can include a set of magnetic elements163′, 163″, embedded in a magnetic diaphragm 160′, situated between thefirst and second chambers. Elements (e.g., magnetic elements) of thediaphragm 160 can possess any suitable shape, including one or more ofa: bar, cross, sphere (e.g., ball bearing), and/or any other suitableshape or combination of shapes. Alternatively, the diaphragm itself canbe made of magnetic material (e.g., ferrous material). Alternatively,the diaphragm can reversibly house the magnetic elements. In oneexample, driving element coupling and torsion along a keying interfacedefined in the diaphragm can open a door that releases the magneticelement(s). However, the magnetic elements can be otherwise supported bythe diaphragm. The magnetic element can be arranged along an inferiorsurface of the diaphragm (e.g., surface proximal the second chamber), asuperior surface of the diaphragm (e.g., surface proximal the firstchamber), embedded within the diaphragm thickness, or otherwisearranged. In a specific example (shown in FIG. 24), the grindingelements of the diaphragm can be magnetic, wherein the grinding elementsalso function as the magnetic elements in the second configuration(e.g., mixing mode). However, the diaphragm 160 can house, include,and/or be embedded with any suitable components possessing any suitableshape. When the diaphragm includes multiple magnetic elements, themultiple magnetic elements can have the same polarity or differentpolarities. Alternatively, each magnetic element can include a north andsouth pole. However, the magnetic elements can be otherwise configured.

The diaphragm 160 can include one or more diaphragm grinding features165. The one or more diaphragm grinding features 165 preferably extendaway from a broad face defined by the diaphragm 160 (grinding face). Thegrinding face can: be proximal the first chamber, define the firstchamber, be defined by the first chamber, proximal the second chamber,define the second chamber, be defined by the second chamber, or beotherwise defined. Additionally or alternatively, the one or morediaphragm grinding features 165 can be physically connected to anopposing broad face proximal the second chamber 130, where the diaphragmgrinding features 165 can further facilitate homogenization of theconsumable sample in the second chamber 130 (e.g., contemporaneouslywith mixing the consumable sample with processing reagent in the secondchamber 130). However, the diaphragm 160 can include diaphragm grindingfeatures 165 arranged at any suitable location along the diaphragm 160.The diaphragm grinding features 165 are preferably shorter than thelength of the first chamber, but can alternatively be longer orsubstantially equal in length. The diaphragm grinding features 165 caninclude one or more fins, protrusions, plungers, sharp edges, dulledges, and/or any suitable feature for mechanical processing of theconsumable sample. In examples, the diaphragm grinding features 165 canhave magnetic properties (e.g., be constructed with magnetic material),include one or more magnetic elements 163, and/or have any suitablerelationship with magnetic elements 163.

The diaphragm 160 is preferably at least partially constructed withfrangible materials or configurations (e.g., used for a frangible region161 of the diaphragm 160), thereby enabling destruction of the couplingmechanism between the diaphragm 160 and an interior wall of the testcontainer body (e.g., an interior wall of the first chamber 110, aninterior wall of the second chamber 130, etc.), leading to operation ofthe diaphragm 160 in a mixing mode for mixing the consumable sample withprocessing reagent in the second chamber 130. Additionally oralternatively the diaphragm 160 can be constructed using degradablematerials, non-degradable materials, glass, metal, ceramic, plastic, orany other suitable material or combination thereof. The frangible region161 can be defined by: frangible material (e.g., brittle material, suchas ceramic), a thinned portion (e.g., with less than a thresholdthickness, such as 1 mm), a perforated portion (e.g., wherein holes areperiodically drilled along the frangible region), or be otherwisedefined. The frangible region 161 can extend: along an arcuate regionarranged radially inward of the diaphragm perimeter (e.g., as shown inFIG. 19), along the diaphragm perimeter, along a chord of the diaphragm,along a radius of the diaphragm, along a diameter of the diaphragm, oralong any other suitable location. The frangible region(s) can bearranged between adjacent magnetic elements (example shown in FIG. 23),arranged between diaphragm grinding features 165 (example shown in FIG.24), arranged between a magnetic element 163 and a diaphragm grindingfeature 165 (example shown in FIG. 25), or be otherwise arrangedrelative to multiple magnetic elements.

The frangible region is preferably configured to break (and transitionthe diaphragm 160 from a first configuration (e.g., a retention modeimpeding flow of the consumable sample from the first chamber 110 to thesecond chamber 130) to a second configuration (e.g., a mixing mode wherethe diaphragm 160 acts as a mixing element 134 in the second chamber130). In an example, the frangible region 161 is preferably constructedwith frangible materials facilitating a clean break (e.g., with fewresidual particles) of the frangible region 161, such that theconsumable sample is not mixed with residual particles of the frangibleregion 161 of the diaphragm 160 when the consumable sample is mixed inthe second chamber 130. Alternatively, the frangible region 161 can beotherwise configured to minimize interference with downstream processingand analysis (e.g., in a second chamber 130, in an analysis chamber 140,etc.) of the consumable sample. However, the frangible region 161 can beconfigured in any suitable manner.

Alternatively, the diaphragm can be removably coupled to the testcontainer by the diaphragm perimeter, wherein the diaphragm is threadeddown to the last thread within the first chamber. The diaphragm ispreferably twisted by the driving element and falls off the last threadwhen the driving element (e.g., cap) is screwed down or forced down intothe first chamber. However, the diaphragm can be otherwise removablycoupled to the test container.

In another example, the processing reagent can be delivered from adiaphragm 160 (e.g., processing reagent housed within a magneticdiaphragm including one or more magnetic elements and one or moreprocessing reagents). Delivery from a diaphragm 160 can be through oneor more of: holes in the diaphragm 160, degradation and/or breakage ofthe diaphragm 160 (and/or reservoir or pouch on the diaphragm), and/orany other suitable mechanism. However, the process reagent and/or anyother suitable solution can be delivered to the second chamber 130and/or other component of the system 100 in any suitable manner.

The diaphragm 160 preferably has a first configuration 167 that retainsat least a portion of the homogenized sample within the diaphragm 160and a second configuration 168 that facilitates delivery of thehomogenized sample into the sample reception opening 132 of the secondchamber 130. In relation to the plunger 128 of the driving element 120described above, the plunger 128 can be configured to be depressed orotherwise moved in any other suitable fashion in order to transition thediaphragm 160 between the first configuration 167 and the secondconfiguration 168. In a first variation, the first configuration 167 isa raised configuration wherein a majority of the diaphragm 160 issituated within the first chamber 110, and openings of the diaphragm 160are accessible from within the first chamber 110. In the firstvariation, the second configuration 167 is a depressed configurationwherein a majority of the diaphragm 160 is situated within the secondchamber 130, and openings of the diaphragm 160 are substantiallyinaccessible from within the first chamber 110 (but open to the secondchamber 130). In this variation, the diaphragm 160 can include at leastone lip 169 circumscribing a portion of the diaphragm, wherein the lip169 functions as a stop that constrains a range of motion of thediaphragm 160 between the first configuration 167 and/or the secondconfiguration 168. Variations of the diaphragm 160 can, however, omit alip 169. For instance, in variations wherein the diaphragm 160 canfunction as a mixing element 134, as described above, the diaphragm 160can be configured to enter the second chamber 130 (e.g., drop entirelyinto the second chamber 130), and function as a mixing element thatcomplements a mixing module of an analysis device 205. In a secondvariation, the first configuration 167 of the diaphragm 160 is anundeformed configuration, wherein a majority of the diaphragm 160 issituated within the first chamber 110, and openings of the diaphragm 160are accessible from within the first chamber 110. In the secondvariation, the second configuration is a deformed configuration wherebyat least one portion (e.g., the roof 164) of the diaphragm 160 isdeformed to drive homogenized portions of the consumable sample from aninterior portion of the diaphragm 160 and into the second chamber 130.In any of these variations, the diaphragm can be configured to bereversibly transitioned between the first configuration 167 and thesecond configuration 168; however, the diaphragm 160 can alternativelybe configured to not be reversibly transitioned between the firstconfiguration 167 and the second configuration 168.

In a third variation, the diaphragm 160 is assembled in the firstconfiguration 167 through injection molding of the diaphragm with thetest container at interior walls of the first chamber 110 (e.g.,interior walls defining the second opening 114 of the first chamber 110)and/or interior walls of the second chamber 130 (e.g., interior wallsdefining the sample reception opening 132). The injection moldingpreferably creates a weak physical coupling between the diaphragm 160and the interior walls of the first chamber 110 and/or second chamber130 (e.g., the frangible region 161). In providing weak coupling, by wayof an injection molding process, completion of twisting of the drivingelement 120 (e.g., test container cap) of the test container 105 canresult in a component (e.g., grinder 122, shearing protrusion 124, etc.)of the driving element 120 applying a temporary force (e.g., crackingforce) to the diaphragm 160 (e.g., to the frangible region 161), therebybreaking coupling between the diaphragm 160 and an interior wall of thetest container 105, to cause the diaphragm 160 to be released into thesecond chamber 130.

In the fourth variation, destruction of the frangible region 161 ispreferably facilitated by an applied force of a grinder 122 (e.g., aplunger 128 of the grinder 122, a shearing protrusion 124″ of thegrinder 122, etc.) of the driving element 120 physically interactingwith the frangible region 161. Additionally or alternatively, thefrangible region 161 can break through one or more of: dissolution(e.g., a dissolvable frangible region 161), melting, mechanical forceapplied by a component (e.g., a component of the analysis device 205, acomponent of the test container 105) other than the driving element 120(e.g., a shear force, an axial force, etc.), and/or through any othersuitable mechanism enabling the breakaway of the diaphragm 160. In anexample of the fifth variation where the diaphragm 160 is a magneticdiaphragm 160′, breakaway of the magnetic diaphragm 160′ can befacilitated by magnetic attraction between magnetic elements 163 of themagnetic diaphragm and complementary magnets (e.g., of the mixing module230). In another example of the fifth variation, the frangible region isat least partially destructed by an actuating element of the analysisdevice 205, the actuating element configured to apply a mechanical forceto the frangible region 161 when the test container 105 and the analysisdevice 205 are in an alignment configuration 211. However, the testcontainer 105 and/or analysis device 205 can include any suitablestructural elements configured to facilitate destruction of one or morefrangible regions 161 of one or more diaphragms 160.

In a fifth variation, the test container 105 includes one or moremagnetic diaphragms 160. A magnetic diaphragm 160′ can include one ormore magnetic elements 163, can be constructed with magnetic materials,and/or include any suitable components conferring magnetic properties tothe magnetic diaphragm 160′. Magnetic elements 163 of a magneticdiaphragm 160′ can be embedded in the magnetic diaphragm 160′, and/orpositioned at any suitable location of the magnetic diaphragm 160′. Themagnetic diaphragm 160′ preferably possesses magnetic properties in afirst configuration (e.g., a retention mode obstructing consumablesample flow) and in a second configuration (e.g., a mixing mode wherethe magnetic diaphragm acts as a mixing element in magnetically-drivenmixing of the consumable sample in the second chamber 130), but canpossess magnetic properties in any suitable configuration.

In examples of the fifth variation, one or more magnetic elements 163are magnetically coupleable with a complementary magnet of a mixingmodule 230 of an analysis device 205. Magnetic coupling with thecomplementary magnet preferably facilitates mixing of the homogenizedsample with processing reagent housed in the second chamber 130.Additionally or alternatively, the one or more magnetic elements 163 canbe magnetically coupleable with any suitable magnet of the system 100.In these examples, interior walls of the second chamber can definemixing features configured to facilitate magnetic coupling between amagnetic element 163 and a complementary magnet. For example, aninterior wall of the second chamber 130 can define indentations (e.g.,concave dimples) geometrically complementary to a magnetic element 163and/or a portion of the diaphragm housing a magnetic element 163.However, the second chamber 130 and/or components of the test container105 can include any suitable features facilitating magnetic coupling ofmagnetic elements of the system 100.

The diaphragm 160 can additionally or alternatively include a temporaryobstruction region 166, opposite the roof 164, that retains at least aportion of the homogenized sample within the diaphragm 160. Retention ofthe portion of the homogenized sample can be performed by the temporaryobstruction region 166 in the first configuration 168 of the diaphragm160, and/or in any other suitable configuration of the diaphragm 160. Inone example, the temporary obstruction region 166 can include adissolvable membrane configured to dissolve and release the homogenizedsample into the second chamber 130 after a desired condition (e.g., acondition involving a threshold volume of the homogenized sample withinthe diaphragm) has been met. In another example, the temporaryobstruction region 166 can include a screen (e.g., a mesh screen, afilter) configured to further facilitate processing of the consumablesample/homogenized sample to have a desired particle dimension prior totransmission into the second chamber 130. The temporary obstructionregion 166 can, however, include any other suitable materials and/or beconfigured in any other suitable manner.

In relation to the test container chambers, including one or more of afirst chamber 110 (e.g., grinding chamber), a second chamber 130 (e.g.,mixing chamber), and/or an analysis chamber 140, one or more pressurestabilization holes can be defined at interface regions between two ormore chambers. For example, the diaphragm 160 can include one or morepressure stabilization holes (e.g., extending through the thickness ofthe diaphragm 160. The pressure stabilization holes preferably stabilizethe pressure differences between chambers of the test container in orderto facilitate the flow (e.g., gravitational flow) of volumes within andbetween chambers. However, the flow of volumes between chambers of thesystem 100 can be facilitated in any other suitable manner.

While a first chamber 110 and a second chamber 130 are described above,in some variations, the test container 105 can include a single chamberconfigured to perform the functions of the first chamber 110 and thesecond chamber 130. For instance, in one variation, the first chamber110 and the second chamber 130 can be physically contiguous as a singlechamber can be used to receive a consumable sample, and to facilitategrinding and mixing of the consumable sample with one or more processreagents to extract and/or dilute a test sample for delivery to adetection substrate 150 for analysis. As such, the first chamber 110 andthe second chamber 130 can be distinct from each other, or otherwiseintegrated into a single chamber that facilitates all sample processingperformed using the system 100.

3.1.E Test Container—Analysis Chamber

The analysis chamber 140 functions to position a detection substrate 150proximal the outlet port 136 of the second chamber, such that thedetection substrate 150 can absorb a volume of the dispersion andprovide indication of presence of at least one harmful substance withinthe consumable sample. The analysis chamber 140 is preferably coupled toat least one of the second chamber 130 and the first chamber, and in onevariation, the analysis chamber 140 is configured external to the secondchamber 130, with access between the second chamber 130 and the analysischamber 140 provided by the outlet port 136 of the second chamber 130.In an example of this variation, the analysis chamber 140 can include aslot longitudinally spanning a portion of the test container 105, asshown in FIG. 2B, wherein the slot is configured to position thedetection substrate 150 proximal the outlet port 136. Portions of theanalysis chamber 140 and/or components of the analysis chamber 140(e.g., detection substrate iso) are preferably aligned, adjacent, and/orproximal along a lateral axis of the first chamber 110 and/or secondchamber 130, but can be in any suitable configuration with any suitablecomponent. However, the analysis chamber 140 can alternatively beconfigured in any other suitable manner.

The detection substrate 150 functions to indicate presence of ananalyte, associated with a harmful substance, and in variations, canindicate presence based upon one or more of: a color change,fluorescence emission, infrared emission, magnetic response, electricalresponse, acoustic change, and any other suitable mechanism ofindication. The detection substrate 150 is preferably a permeablesubstrate (e.g., test strip) that soaks up a portion of the dispersionand facilitates binding of one or more analytes in the dispersion withcomplementary antibodies (e.g., antibodies bound to cellulose nanobeads)at the detection substrate 150, to provide indication of presence ofharmful substances associated with the analyte(s). The detectionsubstrate 150 can include a single active region (e.g., a band, a line,a dot, etc.) for analyte binding, or a set of active regions for analytebinding. The active region(s) can include antibody cocktails for asingle analyte associated with a harmful substance, a set of analytesassociated with different harmful substances, and/or a control regionconfigured provide a control readout (e.g., in order to enabledetermination of a baseline signal, in order to establish properconductance of a test). For instance, in some variations of a detectionsubstrate 150 with a set of active regions 151 for analyte binding, oneactive region can be used as a test region that is used to indicate anamount (e.g., concentration, volume, mass) of a harmful substance in aconsumable sample, and another active region can be used as a controlregion that indicates that the test has been performed properly (i.e.,such that data generated from the detection substrate 150 is reliable).The detection substrate 150 preferably includes a beginning region andan end region respectively defining the beginning and end portions of asample fluid path through the detection substrate 150. In a specificexample, the analysis chamber 140 can include a detection substrate 150extending along a longitudinal axis of the test container body, thedetection substrate 150 including a beginning region fluidly connectedto the second chamber 130 through the outlet port 136 of the secondchamber 130, and an end region proximal the consumable reception openingof the first chamber 110. However, the beginning and end regions of adetection substrate 150 can have any suitable positional relationshipwith other components of the test container 105.

In variations, a region of a detection substrate 150 can be configuredto accommodate an analyte with a single binding site, or multiplebinding sites (e.g., as in a sandwich assay having a first antibody thatserves as a capture antibody, and a second antibody that serves as ananalyte-specific antibody). However, the detection substrate 150 canadditionally or alternatively include any other suitable liquid mediumor sensor configured to indicate presence of a harmful substance withinthe consumable sample in any other suitable manner. In an example, thedetection substrate 150 is a long, narrow, and flat strip of a fibrousmaterial with regions (e.g., bands, lines, spots) of complementaryantibodies to an analyte associated with a harmful substance, wherebycapillary soaking of the detection substrate 150 distributes thedispersion across the detection substrate 150. In a version of theexample for gluten testing, the detection substrate 150 includes acontrol band and a test band, having a distribution of a G12 antibody,bound to cellulose nanobeads, which is configured to bind to the 33-merpeptide of the alpha-gliadin molecule in gluten.

In a variation, the analysis chamber 140 can include a detectionsubstrate 150 including microfluidic pathways, including channels on apatterned-paper, lab-on-a-disc, lab-on-a-chip, and/or any other suitablemicrofluidic devices facilitating detection of target substances in theconsumable sample. Additionally or alternatively, the analysis chamber140 and/or detection substrate 150 can include any suitable elementsdescribed in U.S. Application Ser. No. 15/065,198, filed 9 Mar. 2016,which is herein incorporated in its entirety by this reference.

In some variations, the analysis chamber 140 can include a detectionwindow 142 that enables detection of presence of a harmful substance atthe detection substrate 150. As such, the detection substrate 150 can beconfigured to align with the detection window, such that indicators(e.g., one or more lines generated during binding of analyte at thedetection substrate) can be observed through the detection window 142.The detection window 142 can substantially span an entirety of thedetection substrate, or can alternatively be configured to provideobservation of one or more regions of interest of a detection substrate150. Furthermore, the detection window 142 can include an openingthrough the analysis chamber 140, and can additionally or alternativelyinclude a covering (e.g., transparent covering, translucent covering)that enables observation of the detection substrate 150. In variations,the detection window 142 can further function to indicate potentialdefectiveness of a test container 105, detection substrate 150, and/orany other suitable portion of the system 100 in providing reliableresults. For instance, in some variations, wherein detection substratesare sensitive to heat and/or humidity, the detection window 142 can beconfigured to indicate subjection of a detection substrate 150 to hightemperatures (e.g., above 40° C.) and/or humid environments (e.g., byproducing a color change in the detection window, by having thedetection window fog up, etc.). Additionally or alternatively, the testcontainer 105 can be coupled with a dessicant to preventhumidity-induced damage, and furthermore, variations of the detectionwindow 142 can additionally or alternatively provide any other suitablefunction that provides information regarding potential defectiveness ofa test performed using the detection substrate 150, defectiveness inanalyte detection, and/or any other suitable function. For instance, thedetection window 142 can provide optical qualities that provide desiredproperties upon illumination in order to enhance analysis of a detectionsubstrate 150. Variations of the analysis chamber 140 can, however,entirely omit the detection window 142. For instance, a variation of thesystem 100 can be configured such that the detection substrate isretrieved after contacting a volume of the dispersion, and analyzed awayfrom an analysis chamber 140 of a test container 105.

In variations with a detection window 142, the detection window 142preferably constructed with materials and or sealants preventing liquid(e.g., dispersion, consumable sample, etc.) from unintentionally leakingfrom the test container 105 (e.g., onto other components of the testcontainer 105, onto the analysis device 205). The detection window 142is preferably coupled to the remaining test container 105 with a sealant(e.g., heat seal), but can additionally or alternatively be coupled tothe test container through adhesives (e.g., UV glue), press fitting(e.g., ultrasonic), and/or any other suitable mechanism. The detectionwindow 142 is preferably made of a rigid material (e.g., brittleplastic, plastic blend, etc.) that prevents a user from piercing thedetection window 142. Additionally or alternatively, the detectionwindow 142 can be made of a softer material and/or any other materialpossessing any suitable characteristic. In providing modularity, thedetection window 142 can be made of multiple components and/ormaterials. For example, the detection window 142 can include a rigidcomponent to prevent user penetration and a softer component tofacilitate penetration by the valve plunger. However, the detectionwindow can be assembled with any suitable materials and/or sealants.

3.1.F Test Container—Motor Cavity

As shown in FIGS. 18 and 21, the test container 105 can additionally oralternatively include a motor cavity 170, which functions to align thetest container 105 and the analysis device 205 (e.g., facilitateorientation in an alignment configuration 211). The motor cavity 170 canadditionally or alternatively function to facilitate engagement of themixing module 230 with test container components (e.g., magneticelements 163). The motor cavity 170 is preferably proximal the testcontainer bottom 107, and is preferably aligned with the first andsecond chambers 110, 130 along a longitudinal axis of the test container105. However, the motor cavity 170 can have any suitable positionalrelationship with components of the test container 105 and/or analysisdevice 205. Further, the motor cavity 170 preferably does notcooperatively define the sample fluid path, such that consumable sampleand/or other fluid components (e.g., reagent) do not interface with theinterior of the motor cavity 170, but the motor cavity 170 canalternatively define a portion of the sample fluid path (e.g., a motorcavity 170 additionally serving as a processing chamber). In thealignment configuration 211 between the test container 105 and theanalysis device 205, the motor cavity 170 preferably substantially orfully encloses the mixing module 230 (e.g., a mixing motor and acomplementary magnet), but can additionally or alternatively house anyother suitable component (e.g., a valve motor for transitioning theoutlet port 136 from a closed to an open configuration). In a specificexample, the motor cavity 170 additionally or alternatively houses asensor (e.g., a weight sensor, a light sensor, etc.) for measuringcharacteristics of the consumable sample in the second chamber 130.However, the motor cavity 170 can be configured in any suitable manner.

Variations of the test container 105, as noted earlier, can becharacterized by modularity in using a combination of reusable and/ornon-reusable components, such that portions of the test container 105can be reused, and other portions of the test container 105 can bedisposed after a limited number of uses. For instance, in somevariations, all portions of the test container 105 can be configured tobe reusable, aside from the detection substrate 150/analysis chamber140, such that the detection substrate 150 are disposed after each use,and the test container 105 can be reused for another instance ofdetection upon replacement of the detection substrate iso/analysischamber. In other variations, all portions of the test container 105 canbe configured to be reusable, aside from the detection substrate 150,such that the detection substrate 150 are disposed after each use, andthe test container 105 can be reused for another instance of detectionupon replacement of the detection substrate 150. The test container 105can, however, provide any other suitable combination of reusable anddisposable components. In providing modularity, portions of the testcontainer 105 are preferably made of a material that is recyclable,compostable and/or processable, and in variations, can include any oneor more of: a polymer (e.g., a plastic), a metal, and a glass. Forexample, a portion of the test container 105 can be made of acompostable material, while the detection window 142 of the testcontainer can be made of a recyclable plastic. However, variations ofthe test container 105 can alternatively include any other suitablematerial (e.g., ceramic), and can be configured to be entirely reusableor entirely disposable.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the embodiments of the test container 105 withoutdeparting from the scope of the test container 105.

3.1.G Test Container—Test Container Body

As shown in FIG. 20, the test container can additionally oralternatively include a test container body, which functions to providemechanical support and/or shielding to components of the test container105. The test container body can include a test container top 106, atest container bottom 107 opposing the test container top 106, and/orany suitable number of side walls 108 physically connecting the testcontainer top 106 and the test container bottom 107. However, the testcontainer body can include any suitable components in any suitableconfiguration.

As shown in FIG. 20, in a variation, the test container body can bekeyed (e.g., possess an asymmetric profile) for insertion into theanalysis device 205. For example, the test container 105 can include acurved side wall 108′ and a flat side wall 108″. In another example, thetest container body can define a test container top geometricallyasymmetric from a test container bottom. In a specific example, the testcontainer body can define a curved side 108′ physically connected to thetest container top 106 and the test container bottom 107, wherein thecurved side is proximal the first chamber 110 and the second chamber 130of the test container 105. In this specific example, the test containerbody can additionally or alternatively define a flat side 108″ opposingthe curved side 108′ and physically connected to the test container top106 and the test container bottom 107, wherein the flat side 108″ isproximal the analysis chamber. In a second example, the test container105 can define a cross section including a tongue, complementary to agroove defined by the analysis device opening. However, the testcontainer body can be configured in any suitable manner.

3.2 System—Analysis Device

As noted above and shown in FIG. 1, in an embodiment, the analysisdevice 205 includes: a receiving port 210 configured to receive the testcontainer 105, a mixing module 230 configured to mix the homogenizedsample with a process reagent, an optical sensing subsystem 220configured to enable detection of presence of the harmful substance atthe detection substrate 150, and a processing and control system 240configured to receive and process signals from the optical sensingsubsystem 220, thereby producing an output indicative of presence of theharmful substance in the consumable sample.

As shown in FIG. 16A, in variations, the analysis device 205 can includeand/or define a base 206 and one or more triangular faces 207 physicallyconnected to the base 206, the one or more triangular faces 207 definingan apex 208. In a specific example, the analysis device 205 can becharacterized by a triangular prism form including a base 206 and twotriangular faces 207 extending substantially normally from opposingsides of the base. The analysis device 205 can additionally oralternatively include side walls physically connected to the base 206and physically connecting the one or more faces 207. The side walls canbe flat, curved, and/or otherwise configured. However, the analysisdevice 205 and/or components of the analysis device 205 can be definedby any suitable geometric characteristics.

3.2.A Analysis Device—Receiving Port

The receiving port 210 functions to receive the test container 105, andcan additionally function to align the test container 105 to facilitatedetection of analytes at a detection substrate, in cooperation with theoptical sensing subsystem 220. The receiving port 210 preferably definesa test container opening sized to receive the test container 105. Assuch, the receiving port 210 preferably mates with the test container105 (e.g., an external morphology of the test container 105), in aconsistent manner, such that the test container 105 can only bepositioned within the receiving port 210 of the analysis device in oneof a discrete set of orientations (e.g., in variations wherein the testcontainer 105 has an orientation). In a specific example, the receivingport can be geometrically complementary to the test container 205, wherethe receiving port 210 can include a superior portion geometricallycomplementary to a test container top 106, and an inferior portiongeometrically complementary to a test container bottom 107.Alternatively, in variations wherein the test container 105 is symmetric(e.g., having a rotational axis of symmetry), the receiving port 210 canbe configured to accommodate symmetry in the test container 105 inrelation to positioning the test container 105 relative to otherelements of the analysis device 205 (e.g., the optical sensing subsystem220, the mixing module, 230). While the receiving port 210 can receive atest container 105 into an interior portion of the analysis device 205,receiving port 210 can additionally or alternatively be configured tocouple the test container 105 to an external portion of the analysisdevice 205. For instance, the receiving port 210 can include a mechanism(e.g., latch, slide, magnet) configured to couple the test container 105to at least a portion of the exterior of the analysis device 205.

In variations where the analysis device 205 defines a base 206 and atriangular face 207, the test container opening of the receiving port210 can be proximal an apex 208 of the triangular face 207. Further, alongitudinal axis of the receiving port 210 can be substantiallyparallel a side of the triangular face 207 and/or angled with respect tothe base 206 (e.g., perpendicular the base). Additionally oralternatively, a lateral axis of the receiving port can intersect aplane of the base 206. In this variation, a test container 105 canpreferably be placed at the test container opening proximal the apex208, and the test container 105 can be guided (e.g., slid,gravitationally driven, with guiding rails, etc.) into an alignmentconfiguration 211 with the analysis device 205. However, the receivingport 210 can be oriented in any suitable configuration with respect tothe analysis device 205 and/or test container 105.

As such, in some variations, the receiving port 210 is preferablyconfigured to receive the test container 105 in an alignmentconfiguration 211, and to release the test container 105 from theanalysis device 205 in a releasing configuration 212 (e.g.,post-analysis of a sample), as shown in FIGS. 9A-9C. In producing thealignment configuration 211, the receiving port 210 can be coupled to acap 213 or other mechanism (e.g., latch, tab, etc.) that facilitatesretention (e.g., locking) of the test container 105 in the alignmentconfiguration, thereby preventing undesired deviations from thealignment configuration, which could affect analysis of a detectionsubstrate 150 of the test container 105. In variations of the receivingport 210 with a cap 213, the cap 213 can further function to facilitateprocessing of a consumable sample and/or homogenized sample within thetest container. For instance, in one variation, the cap 213 can includean actuating element 214 (e.g., disposed within an interior surface ofthe cap 213, accessible from an exterior surface of the cap 213, etc.)configured to depress a plunger 128 of the test container 105 totransition a diaphragm between the first chamber 110 and the secondchamber 130 of the test container 105 between a first configuration 167and a second configuration 168, as shown in FIGS. 9D and 9E. Theactuating element 214 can be magnetically driven, pneumatically driven,mechanically driven (e.g., using springs, etc.), or driven in any othersuitable manner. Actuation of a plunger 128, as facilitated by the cap213, in this variation can be automatically performed once the testcontainer 105 is in the alignment configuration within the receivingport 210, and/or can be triggered (e.g., by the user, by a controlsystem of the analysis device 205) in any other suitable manner. Assuch, in an example workflow of this variation, a user can place a testcontainer 105 within the receiving port 210 of the analysis device, withthe consumable sample substantially homogenized and the diaphragm 160 inthe first configuration 167, and closing of the cap 213 canautomatically initiate depressing of the plunger 128 to transition thediaphragm 160 into the second configuration 168 (e.g., without knowledgeby the user). Then, after detection using the optical sensing subsystem220, as described below, the cap 213 can be opened and the testcontainer 105 can be released from the analysis device 205 in thereleasing configuration. In variations, locking and unlocking of thetest container 105 from the analysis device 205 can be manuallytriggered (e.g., by a user) through mechanical instructions (e.g., abutton, switch), audio instructions (e.g., voice control, etc.), visualinstructions (e.g., a hand gesture, etc.), touch instructions (e.g.,tap, hold, pinch, touching of a digital user interface, pushing and/orpulling force applied to the test container 105 in the receiving port210, etc.), and/or through any suitable mechanism. In other variations,locking and unlocking of the test container 105 can be automaticallytriggered, for example, at specific points along the sample fluid path(e.g., after detection of one or more analytes with the optical sensingsubsystem 220, etc.), after detection of the test container 105 in thereceiving port 210 (e.g., by a test container detection region 215described below, etc.), and/or at any suitable time by any suitablemechanism. However, variations of the receiving port 210 canalternatively omit a cap or other mechanism configured to retain thetest container 105 in the alignment configuration.

As shown in FIG. 22, in another variation, the receiving port 210 caninclude a test container detection region 215 configured to detect thereceipt of the test container 105 at the receiving port 210 in analignment configuration 211. The test container detection region 215preferably includes a translucent region (e.g., constructed with glass,plastic, translucent materials, etc.) adjacent a sensor (e.g., a lightsensor, a motion sensor, etc.) of the test container detection region215. The sensor is preferably configured to determine whether a testcontainer 105 is present in the receiving port 210 and/or whether thetest container 105 is properly in an alignment configuration 211 withthe analysis device 205. Additionally or alternatively, the testcontainer detection region 215 can include any other suitable componentsfacilitating detection of the test container top 105 at the analysisdevice 205.

However, the receiving port 210 and/or components of the receiving port210 can be configured in any suitable fashion.

3.2.B Analysis Device—Mixing Module

The mixing module 230 functions to facilitate active mixing of ahomogenized sample of the test container 105 with a process reagent(e.g., extraction reagent), in order to produce a dispersion that can bedelivered to a detection substrate for analysis. The mixing module 230preferably operates in cooperation with a mixing element 134 of the testcontainer 105 (e.g., of a second chamber 130 of the test container),thereby forming a complementary portion of a mechanism that providessolution mixing. Thus, the mixing module 230 is preferably situatedproximal to a portion of the test container 105 having the homogenizedsample and the process reagent, in the alignment configuration of thetest container 105. As shown in FIG. 21, when the test container 105 andanalysis device 205 are in an alignment configuration 211, the mixingmodule 230 is preferably partially encapsulated by the motor cavity 170of the test container 105, but can additionally or alternatively bepositioned at any suitable location relative the test container 105 inthe alignment configuration 211. As noted above and shown in FIG. 5, themixing module 230 can provide a magnetically-driven mechanism of mixing,an ultrasonic mechanism of mixing, a vibration-based mechanism of mixing(e.g., mechanically driven, acoustically driven), a rocking motion, aspinning-based mechanism of mixing (e.g., by forming a vortex), ashaking-based mechanism of mixing, and any other suitable mechanism ofmixing. In an example wherein the second chamber 130 of a test container105 includes a magnetic mixing element 134, the mixing module 230 caninclude a complementary magnet situated proximal to the second chamber130 in the alignment configuration of the system 100. In the example,the complementary magnet of the mixing module can be coupled to aspinning motor, thereby producing rotation at the magnetic mixingelement 134 within the second chamber 130. In a specific example, themixing module 230 can be proximal the base 206 of the analysis device205, and wherein the mixing module 230 includes a complementary magnetcoupleable to the magnetic element 163 of the magnetic diaphragm 160′,and a spinning motor coupled to the complementary magnet. In variationsof this example, the mixing module 230 can be configured to detectproper coupling between the complementary magnet of the mixing module230 and the magnetic mixing element 134 within the second chamber 130 ofthe test container 105 (e.g., by way of sensing of a magnetic force, byway of detection of motion of the magnetic mixing element 134 inresponse to motion of the complementary magnet, etc.). The mixing module230 can, however, be configured in any other suitable manner.

In a variation, the mixing module 230 can include a mixing status sensorconfigured to start and/or stop mixing based on a determined mixingstatus of the consumable sample in the second chamber 130. One or moremixing status sensors can include a light sensor, weight sensor, phasesensor (e.g., liquid, gaseous, solid phase), etc. Additionally oralternatively, mixing by the mixing module 230 can progress for apredetermined time period (e.g., determined by a manufacturer, by auser, etc.), an automatically determined time period (e.g., based onmixing status sensor readings), and/or for any suitable period of time.

In another variation, the mixing module 230 can include an actuationmotor coupled to a complementary magnet of the mixing module 230, andconfigured to move the complementary magnet in response to completion ofmixing in order to facilitate unimpeded flow of the liquid dispersionfrom the second chamber 130 through the outlet port 136. For example,after completion of mixing the consumable sample with processing reagentin the second chamber 130, an actuation motor of the mixing module 230can move the complementary magnet (e.g., along a guided rail) to aposition proximal a second chamber portion opposing the outlet port 136.However, the mixing module can facilitate consumable sample flow throughthe outlet port 136 in any suitable manner.

However, the mixing module 230 can be configured in any suitablefashion.

3.2.C Analysis Device—Optical Sensing Subsystem

As shown in FIG. 22, the optical sensing subsystem 220 functions tofacilitate detection of one or more analytes, indicative of presence ofa harmful substance within a consumable sample. The optical sensingsubsystem 220 further functions to facilitate automated reading of adetection substrate 150, such that effects of user error are minimized;however, the optical sensing subsystem 220 can be configured to providemanual assessment of test results of a detection substrate 150. Theoptical sensing subsystem 220 is preferably aligned with the detectionwindow 142 of the analysis chamber 140 of the test container 105 in thealignment configuration 211, as shown in FIG. 10, in order to provide acompact configuration and facilitate direct communication between adetection substrate and the optical sensing subsystem 220. In a specificexample where the receiving port 210 defines a first side geometricallycomplementary to a curved side wall 108′ of the test container body, andan optical analysis side opposing the first side and geometricallycomplementary to a flat side wall 108″ of the test container body, theoptical sensing subsystem 220 can be optically aligned with the opticalanalysis side of the receiving port 210. However, in other variations,the detection window 142 of the analysis chamber 140 and the opticalsensing subsystem 220 can alternatively be misaligned, and configured tocommunicate using elements (e.g., mirrors, etc.) that facilitateindirect communication between a detection substrate 150 and the opticalsensing subsystem 220. The optical sensing subsystem 220 preferably hasan adequate sensitivity, resolution, and window of view in order toaccurately and reliably detect signals from a detection substrate 150.In one variation, the sensitivity, resolution, and window of viewcooperate to enable detection of a single analyte at a single region(e.g., dot, line, band) of a detection substrate 150 and in anothervariation, the sensitivity, resolution, and window of view cooperate toenable detection of multiple analytes (e.g., associated with differentallergens) and/or control signals at multiple regions (e.g., dots,lines, bands) of a detection substrate 150. While one optical sensingsubsystem 220 is described, the analysis device 205 can, however,include any other suitable number of optical sensors 220 to facilitatedetection of one or more analytes at one or more regions of a detectionsubstrate 150.

In a first variation, the optical sensing subsystem 220 can include acamera module 221 that is configured to image a detection substrate 150,through the detection window 142, and to generate a distribution (e.g.,array) of pixel intensities corresponding to regions of the detectionsubstrate. Then, in communication with the processing and control system240 (described in further detail below), the distribution of pixelintensities generated from processing of a detection substrate 150 canbe used to output a value of a parameter associated with an amount(e.g., concentration in parts per million, other concentration, mass,volume, etc.) of a harmful substance present in a consumable sampleanalyzed using the detection substrate 150. An example of pixelintensity distributions, prior to and post processing at the processingand control system 240, is shown in FIGS. 11A and 11B, respectively. Thecamera module 221 of the first variation preferably provides data withinsufficient resolution to eliminate a requirement for tight couplingbetween the camera module 221 and a detection substrate 150; however,the camera module 221 can alternatively provide data with any othersuitable resolution.

In the first variation, the camera module 221 can be provided along withan illumination module 222 configured to facilitate illumination of thedetection substrate 150, in order to enable detection of the analyte(s)at the detection substrate. Illumination is preferably provided at anangle (e.g., an acute angle of incidence) relative to a surface of thedetection window 142, in order to minimize reflection (e.g., from thedetection window 142) that could interfere with sensing by the opticalsensing subsystem 220. In specific examples, the illumination module caninclude one or more light-emitting diodes (LEDs) any/or any othersuitable light sources. The LEDs/light sources can be configured toprovide white light, or any suitable range of wavelengths of light.Furthermore, in variations wherein the illumination module 222 includesmultiple light sources, the light sources can be identical in output(e.g., intensity, wavelength) or non-identical in output. As such,illumination can allow an intensity of a desired signal (e.g.,indicative of an analyte associated with a harmful substance) to beenhanced. Illumination can additionally or alternatively function toremove signal interference due to inherent features (e.g., color,acidity, consistency, fermentation, hydrolyzation, etc.) of a consumablesample. For instance, pigmented and/or acidic foods can provide signalinterference in a color-based assay. As such, illumination and ordetection at an optical sensing subsystem 220 of the camera module 221can be enabled in cooperation with one or more filters (e.g., wavelengthfilters, emission filters, excitation filters, etc.) configured tofilter out any interfering signals.

In a second variation, the optical sensing subsystem 220 can include aphotodiode system 223 that is configured to detect absorption and/oremission of light (e.g., wavelengths of light) indicative of presence of(i.e., an amount of) an analyte at a detection substrate incommunication with the photodiode system 223. In one variation, thephotodiode system 223 can include a photodiode configured to detectabsorption of light associated with a peak absorption wavelength of anactive region of a detection substrate (e.g., in order to assessabsorption at a characteristic peak absorption wavelength of anantibody-coated bead bound to an analyte associated with a harmfulsubstance). In one example for gluten detection, the photodiode system223 can include a photodiode configured to detect absorption of 555 nmlight at a detection substrate, wherein cellulose nanobeads treated witha complementary antibody for gluten have an absorption peak at 555 nm.In this example, a higher degree of absorption of 555 nm light (e.g., asindicated by a lower photodiode output) within an active region of adetection substrate 150 is associated with a higher concentration ofgluten in a consumable sample, with an example of output data shown inFIG. 12.

In the second variation, the photodiode system 223 can be provided alongwith an illumination module 222 configured to facilitate illumination ofthe detection substrate 150, in order to enable detection of theanalyte(s) at the detection substrate. Illumination is preferablyprovided at an angle (e.g., an acute angle of incidence) relative to asurface of the detection window 142, in order to minimize reflection(e.g., from the detection window 142) that could interfere with sensingby the optical sensing subsystem 220. In specific examples, theillumination module can include one or more light-emitting diodes (LEDs)and/or any other suitable light sources. The LEDs/light sources can beconfigured to provide light associated with an absorption peak of activeparticles (e.g., antibody-coated nanobeads, colloidal gold particles) atan active region of a detection substrate 150, or any suitable range ofwavelengths of light. These particles can be either chemicallyconjugated with an antibody or more than one antibody, or can have theantibody or antibodies physically adsorbed onto them. Furthermore, invariations wherein the illumination module 222 includes multiple lightsources, the light sources can be identical in output (e.g., intensity,wavelength) or non-identical in output. As such, illumination can allowan intensity of a desired signal (e.g., indicative of an analyteassociated with a harmful substance) to be enhanced. Illumination canadditionally or alternatively function to remove signal interference dueto inherent features (e.g., color, acidity, consistency, fermentation,hydrolyzation, etc.) of a consumable sample. For instance, pigmentedand/or acidic foods can provide signal interference in a color-basedassay. The signal transduction mechanism can be based on any one or moreof: absorption, fluorescence, chemiluminescence, Förster resonanceenergy transfer, electrical transduction, and any other suitable signaltransduction mechanism. As such, illumination and or detection at anoptical sensing subsystem 220 of the camera module 221 can be enabled incooperation with one or more filters (e.g., wavelength filters, emissionfilters, excitation filters, etc.) configured to filter out anyinterfering signals.

The above variations of the optical sensor can be used in combinationand/or provided by the system 100 in any suitable manner. Furthermore,in variations of a detection substrate 150 having multiple activeregions, the optical sensor(s) 220 and/or illumination module(s) 222 canbe provided in units, wherein the number of units is associated with anumber of active regions in a detection substrate. For instance, for adetection substrate 150 having a control region and a test region, thesystem 100 can include two units, each having a photodiode and a lightsource (e.g., a 555 nm light source) configured to target each of thetwo active regions. In variations, however, the optical sensingsubsystem 220 can be supplemented with or replaced with any othersuitable sensor(s) configured to detect presence of an analyte basedupon one or more of: color change, spectral emission, magnetic signals,electrical current, electrical bias, acoustic signals, and any othersuitable mechanism.

3.2.D Analysis Device—Processing and Control System

The processing and control system 240 functions to receive signals fromthe optical sensor 240 and to generate an output indicative of presenceof a harmful substance within the consumable sample, based upon signalsgenerated from a detection substrate. The processing and control system240 can further function to control operation of the analysis device205, such that detection of one or more analytes associated with harmfulsubstances in a consumable sample is, at least in part, automated. Assuch, the processing and control system 240 can include a processingmodule 242 configured to receive signals from the optical sensingsubsystem 220 and a control module 244 configured to control operationof the analysis device.

The processing module 242 is preferably configured to condition signalsgenerated at the optical sensor(s) 220, and can be directly coupled toan output of the optical sensor(s) 220. Alternatively, the processingmodule 242 can be configured to retrieve data generated from an outputof an optical sensing subsystem 220 from a storage module or in anyother suitable manner. The processing module 242 can thus be configuredto perform any one or more of: denoising, filtering, smoothing,clipping, deconvolving, standardizing, detrending, resampling, andperforming any other suitable signal-processing operation on outputsignals from the optical sensor(s) 220. In variations, wherein an outputof the optical sensing subsystem 220 is image data, the processingmodule 242 can be configured to filter and/or condition image data forsharpness, saturation, edge-finding, intensity, and/or any othersuitable image enhancement. The processing module 242 can further beconfigured to generate an analysis indicative of presence of the harmfulsubstance, wherein the analysis provides information regarding an amount(e.g., concentration, volume, mass) of the harmful substance within theconsumable sample. In one variation involving data from a photodiode,the analysis can enable identification of absorption peaks detected uponillumination of a detection substrate 150 (e.g., over time, taking intoaccount kinetics of a reaction at the detection substrate), andassociate an amount of absorption with an amount (e.g., concentration inparts per million) of an allergen present in the consumable sample. Inone variation involving image data from a camera module, the analysiscan characterize intensity (e.g., average intensity, peak intensity,relative intensity) across an active region of a detection substrate,and associate an intensity parameter (or other image parameter) with anamount (e.g., concentration in parts per million) of an allergen presentin the consumable sample. The processing module 242 can be implementedin one or more processing elements (e.g., hardware processing element,cloud-based processing element), such that processing by the system 100can be implemented in multiple locations and/or phases.

In variations, the control module 244 can be configured to control anyone or more of: retaining a test container 105 within the analysisdevice 205 in an alignment configuration, facilitating release of thetest container 105 from the analysis device 205 in the releasingconfiguration, depressing of a plunger 128 of the test container 105(e.g., to transition a diaphragm 160 of the test container 105 between afirst configuration and a second configuration), mixing of thehomogenized sample with a process reagent upon transmission of commandsto the mixing module 230, activation of a valve 138 of a second chamber130 of the test container 105 in order to initiate delivery of a volumeof a dispersion to a detection substrate 105, illumination of adetection substrate 150 upon transmission of commands to an illuminationmodule 223, transmission of outputs of an optical sensor forconditioning an processing by the processing module 240, and any othersuitable operation for automation in use of the system 100.

Modules of the processing and control system 240 can be implemented atany one or more of: on-board at the analysis device 205 that receives atest container 105, at a portion of the test container (e.g., usingelectronics integrated into the test container 105), and at any othersuitable processing subsystem. For instance, modules of the processingand control module 240 can be implemented at a mobile device (e.g.,smart phone, tablet, head-mounted computing device, wrist-mountedcomputing device) in communication with the analysis device 205, suchthat some amount of data processing and/or control of a test container105 or analysis device 205 is implemented using the mobile device.Additionally or alternatively, modules of the processing and controlsystem 240 can be implemented in any other hardware-based or cloud-basedcomputing system configured to communicate with the system 100described.

The processing and control system 240 can additionally or alternativelyinclude a communications module (e.g., a Bluetooth low energy chip) forcommunication of recorded and/or stored test results to any suitabledevice (e.g., a user device, a remote server, etc.). However, theprocessing and control system 240 can be configured in any suitablemanner.

Furthermore, the analysis device 205 can include any other suitableelements configured to facilitate processing of a test sample (e.g., adispersion generated from a consumable sample that has saturated adetection substrate), and/or reporting of information derived from thetest sample to a user or other entity. In one variation, the analysisdevice 205 can include a module configured to facilitate release of thedispersion from the port 136 of the second chamber 130 to a detectionsubstrate 150 at an analysis chamber 140, in cooperation with a valve138 of the second chamber 130, as described in relation to the port 136above. The analysis device 205 can further include elements that providean indication that the analysis device is in an operational mode (e.g.,as opposed to an off mode, as opposed to a dormant mode), and/orelements that reduce noise (i.e., signal noise, acoustic noise) duringprocessing of a test sample. The analysis device 205 can further includea housing configured to house elements of the analysis device 205 in acompact manner. The analysis device 205 or any other suitable portion ofthe system 100 can further include a power module configured to providepower to the system 100 (e.g., by including an energy storing, energyreceiving, and/or energy distributing element) such as a battery (e.g.,a rechargeable secondary battery, such as a lithium chemistry battery; aprimary battery), a piezoelectric device, and/or any other suitableenergy storage, generation, or conversion system. As shown in FIG. 15,the analysis device 205 and/or system 100 can additionally oralternatively include a display 250 (e.g., of the analysis device 205,of a mobile device in communication with the system 100) configured toconvey information (e.g., results regarding detection of a targetsubstance in the consumable sample) from the system 100 to a user orother entity, and/or any other suitable user interface elements (e.g.,input modules, notification modules, buttons 252 for initiating and/orpausing operations of the system 100, etc.) configured to facilitateuser interaction with the system 100. In a variation where the analysisdevice 205 defines a base 206 and two or more triangular faces 207connected by one or more side walls, a user interface (e.g., an LEDdisplay) can be integrated with one or more of the side walls.Additionally or alternatively, the analysis device 205 can include anyother suitable elements for processing of a test sample in a manner thatis convenient to a user.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the embodiments of the analysis device 205 withoutdeparting from the scope of the analysis device 205.

4. Method

As shown in FIGS. 13 and 14, an embodiment of a method 300 for detectinga target substance in a consumable sample includes: receiving aconsumable sample at a first chamber of a test container including aconsumable reception opening, configured to receive the consumablesample, and a second opening S310; transforming the consumable sampleinto a homogenized sample upon processing of the consumable sampletoward the second opening of the first chamber by way of a drivingelement S320; delivering the homogenized sample from the first chamberto a second chamber of the test container, wherein the second chamber isconfigured to receive the homogenized sample from the second opening ofthe first chamber and includes an outlet port S330; mixing thehomogenized sample with a process reagent within the second chamber,thereby producing a dispersion S340; transmitting a volume of thedispersion to an analysis chamber, of the test container, configured toposition a detection substrate proximal the outlet port of the secondchamber and including a detection window that enables detection ofpresence of the allergen S350; and detecting presence of the harmfulsubstance within the consumable sample by way of an optical sensingsubsystem configured to detect signals indicative of the allergenthrough the detection window S360.

The method 300 functions to receive and process a sample of a consumable(e.g., food, beverage, cosmetic, etc.) in order to enable detection ofone or more harmful substances within the sample. In examples, theharmful substances can include any one or more of: an allergen (e.g.,gluten allergen, a dairy-derived allergen, a nut allergen, a fishallergen, an egg-derived allergen, etc.) a toxin, a bacterium, a fungus,a pesticide, a heavy metal, a chemical or biological compound (e.g., afat, a protein, a sugar, a salt, etc.), and any other suitable harmfulsubstance. The method 300 is preferably configured to impose minimalrequirements upon a consumer using the system 100, in terms oflabor-intensiveness, time-intensiveness, and cost-intensiveness. Assuch, the method 300 is preferably configured to automatically orsemi-automatically process the sample in a manner that is intuitive tothe consumer, and to quickly provide information regarding presence ofthe harmful substance(s) within the sample. The method 300 is preferablyimplemented at least in part by a portion of the system 100 described inSection 1 above; however, the method 300 can alternatively beimplemented using any other suitable system.

Block S310 recites: receiving a consumable sample at a first chamber ofa test container including a food reception opening, configured toreceive the consumable sample, and a second opening. Block S310functions to receive and facilitate processing (e.g., homogenization) ofa consumable sample that the user intends to analyze for presence of aharmful substance. Block S310 is preferably implemented at anembodiment, variation, or example of the first chamber described inrelation to the system 100 above; however, Block S310 can alternativelybe implemented with any other suitable chamber configured to receive asolid and/or liquid sample. As such, Block S310 can include actively orpassively receiving a consumable sample from the user. In variations ofpassive reception, the consumable sample can be tweezed, scooped,spooned, forked, or otherwise delivered into the first chamber in anyother suitable manner. In variations of active reception, the consumablesample can be sucked or forced into the first chamber in any othersuitable manner (e.g., using positive and/or negative pressure).

Block S320 recites: transforming the consumable sample into ahomogenized sample upon processing of the consumable sample toward thesecond opening of the first chamber by way of a driving element. BlockS320 functions to process the consumable sample to have particles of adesired size, and to increase homogeneity of a consumable samplereceived in Block S310, in order to generate reliable results regardingan amount (e.g., concentration, mass, volume) of a harmful substancewithin a consumable sample. Block S320 is preferably implemented usingembodiments, variations, or examples of the first chamber, drivingelement 120, grinder 122, plunger 128, and/or diaphragm 160 of the testcontainer 105 described in relation to the system 100 above; however,Block S320 can alternatively be implemented using any other suitablesystem. As such, in homogenizing the consumable sample, Block S320preferably involves grinding the consumable sample with a set ofprotrusions of a driving element, using a combination of compression androtational motions (e.g., involving threads of the first chamber and thedriving element); however, Block S320 can additionally or alternativelyproduce the homogenized sample in any other suitable manner.

Block S330 recites: delivering the homogenized sample from the firstchamber to a second chamber of the test container, wherein the secondchamber is configured to receive the homogenized sample from the secondopening of the first chamber and includes an outlet port. Block S330functions to deliver the homogenized sample for further processing in acontrolled manner that ensures that homogenized portions of theconsumable sample continue on for further processing, whileun-homogenized portions of the consumable sample are either undeliveredor are retained to be homogenized. Block S330 is preferably implementedusing embodiments, variations, or examples of the first chamber, drivingelement 120, grinder 122, plunger 128, diaphragm 160, and/or secondchamber 130 of the test container 105 described in relation to thesystem 100 above; however, Block S330 can alternatively be performedusing any other suitable system 100. As such, Block S330 can includereceiving homogenized portions of a consumable sample within a cavity ofa diaphragm configured between the first chamber and the second chamber,and delivering homogenized portions of the consumable sample into thesecond chamber by depressing a plunger configured to contact thediaphragm. Block S330 can, however, include delivering the homogenizedsample from the first chamber to a second chamber of the test containerin any other suitable manner.

Block S340 recites: mixing the homogenized sample with a process reagentwithin the second chamber, thereby producing a mixture. Block S340functions to facilitate extraction of analytes, associated with theharmful substance, from the homogenized sample, in order to facilitatedetection of the analytes in subsequent blocks of the method 300. BlockS340 is preferably implemented using embodiments, variations, orexamples of the second chamber 130, the mixing element 134, and/or themixing module 230 described in relation to the system 100 describedabove, however, Block S340 can alternatively be implemented using anyother suitable system. As such, in variations, Block S340 can includeproviding a volume of the process reagent (e.g., prepackaged within thesecond chamber), such that the homogenized sample is automaticallybrought into contact with the process reagent upon delivery between thefirst chamber and the second chamber, as described in relation to BlockS330. Additionally or alternatively, Block S340 can include activelydelivering the process reagent to be mixed with the homogenized sample,by way of a fluid delivery module coupled to the first chamber and/orthe second chamber. In Block S340, the process reagent preferablyincludes an extraction solution configured to extract at least oneanalyte, associated with a harmful substance, from the homogenizedsample, that can be detected at a detection substrate and used toindicate presence of the harmful substance. However, the process reagentcan additionally or alternatively include any other suitable reagents,as described above.

While blocks of the method 300 can occur as distinct steps, in somevariations, portions of at least Blocks S310, S320, S330, and/or S340can be performed substantially simultaneously. For instance, accordingto a variation of the method 300, a consumable sample can combined witha process reagent (e.g., an extraction solution, a dilution buffer,etc.) prior to or during grinding, thereby producing a mixture that canbe delivered from a chamber of a test container and to a detectionsubstrate for analysis.

Block S350 recites: transmitting a volume of the dispersion to ananalysis chamber, of the test container, configured to position adetection substrate proximal the port of the second chamber andincluding a detection window that enables detection of presence of theallergen. Block S350 functions to control delivery of the dispersion toa detection substrate, such that an adequate volume of the dispersion isprovided to a detection substrate to enable analyte detection, whileavoiding flooding of the detection substrate. Block S350 is preferablyimplemented using embodiments, variations, or examples of the secondchamber, outlet port, valve, and/or analysis chamber described inrelation to the system 100 above; however, Block S350 can alternativelybe implemented using any other suitable system. As such, Block S350 caninclude opening a valve (e.g., using a control module) of an outlet portof the second chamber, to deliver a volume of the dispersion to adetection substrate within the analysis chamber. However, Block S350 caninclude any other suitable step for delivery of a volume of thedispersion to the detection substrate.

Block S360 recites: detecting presence of the allergen or othersubstances within the consumable sample by way of an optical sensorconfigured to detect signals indicative of the allergen through thedetection window. Block S360 functions to detect and process signalsgenerated from a detection substrate treated with the dispersion, inorder to generate an analysis that provides information regardingpresence of one or more harmful substances within a consumable sample.Block S360 is preferably implemented using embodiments, variations, orexamples of the analysis chamber, detection substrate, detection window,optical sensor, and/or processing and control system described inrelation to the system 100 above; however, Block S360 can alternativelybe performed using any other suitable system. As such Block S360 caninclude any one or more of: denoising, filtering, smoothing, clipping,deconvolving, standardizing, detrending, resampling, and performing anyother suitable signal-processing operation on output signals from anoptical sensor in communication with a detection substrate saturatedwith the dispersion. In variations of Block S360 involving image data,Block S360 can include filtering and/or conditioning image data forsharpness, saturation, edge-finding, intensity, and/or any othersuitable image enhancement.

In generating an analysis in Block S360, the analysis preferablyprovides information regarding an amount (e.g., concentration, volume,mass) of the harmful substance within the consumable sample. In onevariation involving data from a photodiode, generating the analysis inBlock S360 can include identifying absorption peaks detected uponillumination of a detection substrate 150 (e.g., over time, taking intoaccount kinetics of a reaction at the detection substrate), andassociating an amount of absorption with an amount (e.g., concentrationin parts per million) of an allergen present in the consumable sample.In one variation involving image data from a camera module, generatingthe analysis in Block S360 can include characterizing intensity (e.g.,average intensity, peak intensity, relative intensity) across an activeregion of a detection substrate, and associating an intensity parameter(or other image parameter) with an amount (e.g., concentration in partsper million) of an allergen present in the consumable sample. Block S360can, however, include processing signals derived from a detectionsubstrate saturated with a volume of the dispersion, and/or generatingan analysis in any other suitable manner.

The method 300 can additionally or alternatively include any othersuitable blocks or steps configured to facilitate reception and/orprocessing of a consumable sample, in order to facilitate detection ofthe presence of one or more harmful substances within the consumablesample.

In relation to the system 100, the test container 105, the analysisdevice 205, and/or the aligned system of a test container 105 coupled tothe analysis device can have any suitable dimensions (e.g., width,length, height, surface area, volume, aspect ratio, curvature, flat,etc.). Additionally or alternatively, components of the system 100 canbe defined by any suitable three-dimensional shapes including: a prism(e.g., triangular prism, square prism, polygonal prism, etc.), cube,cylinder, sphere, plate and/or any suitable three-dimensional shape. Theshape of a surface area of a component of the system 100 can include: arectangle, square, circle, triangle, polygon, and/or other suitableshape.

Embodiments of the system 100 and/or method 300 and variations thereofcan be embodied and/or implemented at least in part by a machineconfigured to receive a computer-readable medium storingcomputer-readable instructions. The instructions are preferably executedby computer-executable components preferably integrated with the system100 and one or more portions of the processor 273 and/or the controller272. The computer-readable medium can be stored on any suitablecomputer-readable media such as RAMs, ROMs, flash memory, EEPROMs,optical devices (CD or DVD), hard drives, floppy drives, or any suitabledevice. The computer-executable component is preferably a general orapplication specific processor, but any suitable dedicated hardware orhardware/firmware combination device can alternatively or additionallyexecute the instructions.

The FIGURES illustrate the architecture, functionality and operation ofpossible implementations of systems, methods and computer programproducts according to preferred embodiments, example configurations, andvariations thereof. In this regard, each block in the flowchart or blockdiagrams may represent a module, segment, or portion of code, whichincludes one or more executable instructions for implementing thespecified logical function(s). It should also be noted that, in somealternative implementations, the functions noted in the block can occurout of the order noted in the FIGURES. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or theblocks may sometimes be executed in the reverse order, depending uponthe functionality involved. It will also be noted that each block of theblock diagrams and/or flowchart illustration, and combinations of blocksin the block diagrams and/or flowchart illustration, can be implementedby special purpose hardware-based systems that perform the specifiedfunctions or acts, or combinations of special purpose hardware andcomputer instructions.

Although omitted for conciseness, the preferred embodiments includeevery combination and permutation of the various system components andthe various method processes, wherein the method processes can beperformed in any suitable order, sequentially or concurrently.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

We claim:
 1. A system with a test container for detecting a targetsubstance in a consumable sample, the test container comprising: a testcontainer body defining: a first chamber configured to receive theconsumable sample, the first chamber defining a consumable receptionopening and a second opening opposing the consumable reception opening,and a second chamber defining: a sample reception opening coextensivewith the second opening of the first chamber, wherein the second chamberis configured to receive a homogenized sample from the first chamber,and an outlet port at an inferior portion of the second chamber, whereinthe second chamber is aligned with the first chamber along alongitudinal axis of the test container body; a magnetic diaphragmsituated between the first chamber and the second chamber, the magneticdiaphragm having a first configuration that retains at least a portionof the homogenized sample within the first chamber, the magneticdiaphragm comprising a magnetic element embedded in the magneticdiaphragm; and a driving element geometrically complementary to thefirst chamber, the driving element comprising: a shaft defining a shaftradius smaller than a radius of the consumable reception opening and ahollow channel terminating in a channel opening, a head connected to afirst end of the shaft, the head defining a dimension larger than theconsumable reception opening, and a consumable sample grinding featureextending from an interior surface of the hollow channel.
 2. The testcontainer of claim 1, wherein the shaft defines an end of the shaft,wherein the end of the shaft defines the channel opening of the hollowchannel, wherein the end of the shaft comprises a set of shearingprotrusions extending along a longitudinal axis of the shaft, andwherein a length of the shaft with the shearing protrusions is greaterthan a length of the first chamber.
 3. The test container of claim 2,wherein the magnetic diaphragm defines a frangible region arrangedradially inward from a perimeter of the magnetic diaphragm, thefrangible region supported by an interior wall of the test containerbody.
 4. The test container of claim 3, wherein the magnetic diaphragmcomprises: a broad face proximal the first chamber; and a grindingfeature extending from the broad face towards the consumable receptionopening.
 5. The test container of claim 1, wherein the driving elementcomprises a plunging element extending along a longitudinal axis of theshaft, wherein a length of the plunging element is greater than a lengthof the first chamber.
 6. The test container of claim 5, wherein theplunging element comprises a sharp tip, and wherein the plunging elementis spring-loaded, wherein the plunging element extends from an interiorof the hollow channel toward the channel opening.
 7. The test containerof claim 1, wherein the second chamber houses a processing reagent. 8.The test container of claim 1, further comprising a detection substrateextending along a longitudinal axis of the test container body, thedetection substrate comprising: a beginning region fluidly connected tothe second chamber through an outlet port of the second chamber; and anend region proximal the consumable reception opening of the firstchamber.
 9. The test container of claim 8, wherein the detectionsubstrate is aligned with the first chamber along a lateral axis of thetest container body, and wherein the first chamber, second chamber, anddetection substrate cooperatively define a consumable sample fluid paththrough the test container.